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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
I'm fine with "Fully Funded by BHRT", just add the next page/sheet with the details. A little breakdown. Don't want to overwhelm people with some CPA/MBA level analysis, but a little "detail" I think is all people want. A one pager summary sheet. Again, cost per patient, timeline approx., where they expect the money to come from/be raised from and spread out over X number of months.
Kind of the "bullet-point", Powerpoint one-pager. People like pictures or summary bullet-points that sort of lay out the "big picture". Then, when they, if they choose to read the 10-K or similar- they can say, "Ah-ha, yep- here's that cost break down, and here's that equity line or shares sold- I'm cool with that as they laid that out real clear in that presentation."
People just don't like uncertainty or vagueness- again more info is better than less (of course within limit- as I said, don't give um the War and Peace Vol II version, just the one-page summary sheet in a clear, easy to understand plan). People like clear "plans" and then the updates you give can show how you're "on-plan" or give you the chance to give an update and say, "We've deviated from PLAN here, and here's why due to X, Y and Z coming up, so we're making adjustments to the plan". Then people say, "Oh, they're not pulling a fast-one on us or hiding anything- they're just clearly adjusting the plan, and it all makes sense and it jives with what they laid out for us before".
Again, that's my 2 cents. I just think for many people it builds a more confident base and understanding- they may not be as confident as you or have followed the company for as long, etc. They may need to see the long term vision and plan to feel it's a good time to put money on the line and buy-in.
Wishy-washy camp for me too. But for different reason. The part I don't like is the "fully funded by BHRT" type of statements. Now STAY COOL guy's, it's not a "bash", just a legit question. When your last 10-Q showed about $6K on the books left, the logical question to me is, "fully funded HOW?"
A more "common" industry/CEO type response I prefer to see is along the lines of, "We expect the XYZ trial to happen in 3 stages. Stage 1 enrollment is expected to be complete approx XY/2014 and we estimate the cost to be approx. $12K per patient and will enroll 120 patients. Or, this type of trial is being structured where participants will pay a partial fee to be in the study and BHRT will pay the remainder. Stage 2 will be the trial itself and will be conducted at sites, X, Y, Z and A, B, C and we estimate we need to fund each of those site at a cost of $X dollars per patient for the duration of the trial, expected to last 6 months approx and have a total cost of Y dollars. Final stage, stage 3 will be our final data report and compilation and will be done with in-house resources and also via contracting to firm ABC and we estimate this to cost X dollars and terminate approx. 6 months from last patient enrolled. The funding from this will be done via our XYZ stand-by equity line and also via equity sales of shares estimated to be approx X shares over 9 months, which yes, we expect to be partially dilutive, but we believe this is a key step in the company's progress and needs to take place, blah, blah, blah. Our estimate at this time of total cost of the Super-Duper trial is $1.3 million dollars and will be spread out over a 9 month period."
See the difference? See how that would make investors and the professional community so much more confident that they totally know where you're going, how you think you're going to get there, etc? "Fully funded" to me, is a pretty much nothing statement. All it leaves for us, is to wait for something like a 10-Q or 10-K to come out and then hope to find how many more shares were diluted or if we can find more borrowing or where money might of come from and so forth.
Not a big, confidence building statement in my opinion- and that's all it is, my opinion. I've seen big companies, lay out big announcements- and they get a CEO right out there with a Powerpoint presentation and all- to the investment community and show the timeline, expected cost/investment, whether it will be dilutive to shares or earnings per share (obviously not applicable to BHRT at this point), are they going to borrow bond debt, etc.
The more vague you are, the more I think it leaves you open to volatility and people maybe throwing in the towel, people thinking it's stalled out, etc. More info is better than less. Vague= lack of confidence in my book. "Wishy washy" is a good wording to me.
That's pretty much what I'd expect him to say. Talking about a key, trial enrollment and progress/potential lack of progress is about as "material" as it gets. I'd guess he's gotta tread real lightly there. If he's saying wait for 10-K, that pretty much tells me he doesn't have a whole lot of "major" news to give on it yet- or they'd put it out in a PR. As in, lets say they finished total enrollment- I'd think that is about as "PR worthy" an item as you can release, but they can't release it until it's true of course. So he's telling you he can't speak on a major, material event like a trial via private communication and doesn't expect anything on it till the 10-K info. Makes perfect sense to me. So, guess it's wait and see time. The other theories/opinion on "medical tourism" as a potential revenue source (several posts from different people) - I can buy all that as reasonable arguments.
I think they're in a tough spot, so my opinion is don't sugar coat it or overblow it. Cash is tight- I think everyone would say that's a given. But are they trying to "work the problem" from all angles and maybe pull the magic rabbit out of the hat? Yes. If you and I ran a biz and we were say, focused on "Widget Making Inc", but were in a tough econ times or whatever and tight on cash- and we realized that we had the people or facility to make some good, cash money by shifting over at least for a time to "Happy services XYZ" would we do it? I think so. Nothing in biz is cast in stone- as in biz plans, long range plans get revised/updated all the time as times and econ challenges arise, etc. So maybe this is "the new plan" for now and they're working it to see what it can do- while the trial(s) are still there, but cash is the big driver and they have to find out how to get more of it. All reasonable theories/possibilities to me and makes sense.
Does it all work out in the end? If anyone has a brand/model number of a crystal ball that works, guaranteed- send me info cause I want to buy one ASAP and get filthy wealthy. Remember "Back to the Future" with Micheal J. Fox where he finds the Sports Score Statistic book- from the future, well the past really- and realized he can bet and win every time as he now knows the outcome and score of every game before he even bets? Man, what I'd pay to have that, eh?
No sweat. Info is good, more info is always better. This ain't our mom n pops stock market anymore- that much is for certain. It helps for people to understand who/what people like an "Asher" are, or how these private networks can be used, or what it might mean when you see some of these broker/dealer house name/symbols pop up on level II and how much power than can wield around (It wasn't that long ago- that the "little guys" weren't even allowed to see Level II, or you had to pay a small fortune to buy a subscription to get access to it- so at least we got that "fairness" and leveling of the playing field now). But remember, whatever we can see/know if trading actively- a firm like "Asher" or any pro-street firm has 100X the info and speed and access that a retail investor will ever have. Remember the day it went to .063 faster than people could blink? That had to be, in my opinion, one of these big boy firms "cleaning house" or doing whatever it is they do- and the little guys were standing there essentially blind as that "flash crash" happened in minutes. That's a lot of power when they can drop a stock so hard, so fast and no one knows were they short, or selling for someone- or what the heck happened. If we had the same info and speed they had- we'd have all bought that bottom and gone long in a blink- but it's hard to even get orders to fill sometimes when it's moving so fast- you'll see that complaint pointed out here a lot of the time. How people put up an order and these brutal broker/dealers just sit on it, until they can get you up or down to the price and "spread" they want to "make their cut"- it's a brutal game they play. Companies don't get in bed with um cause they're nice guys- it's just that sometimes you gotta do what ya gotta do as times are tough. Good luck.
So are you seeing the "medical tourism" as a specific move, biz decision to enter that space? I posted a few posts back- it doesn't raise any concern they may be getting spread a little thin across too many projects and losing that FDA trial- go, go, go to completion? Any thoughts?
I can see the "medical tourism" as an attempt to generate a "side" cash generator to get money coming in- but they just seem to be getting spread wide and over a lot of territory. It then can pull it off- it's the magic rabbit in the hat. But I would still say I'm a little (not sure the word- disappointed/miffed) at the loss of the previous clear and constant msg that FDA approval was the end all, main game. They used to pound that out constantly- phase III, driving for the end goal of FDA approval in U.S. Just seems that msg is a bit watered down now?
Could all be due to the cash squeeze- and they're just trying for what they can to find revenue sources while trying their best to push trials ahead- I just wonder if the big trail doesn't sputter and peter-out, which was sorta the Marvel problem. That trial had charged ahead full force, made it to phase II, heading to III, then just died out- and in the 10-K and similar they pretty much stated it was only from "lack of funding". So that's the constant pickle they seem to be in. The more a trial moves to phase III, the more money it needs- like the monster that grows as it moves further along. Starting Angel phase I is easy as it's 5 people, but how much cash can/do you need to get it moving now to the next step?
All roads seem to lead back to cash- and there can never be too much it seems. The more the better. We'll have to see I guess- can some of these ventures be the new cash-flow generators?
Interesting article just popped up, sort timed well with the who is ARCA question. It's about the HFT (high speed traders) who for the most part- invented and developed those "private networks" like ARCA you're asking about.
http://finance.yahoo.com/news/high-speed-trading-firms-face-001700904.html
If you ever want a real interesting read- like mind blowing in my opinion, go to Amazon and look up the book "Dark pools" by Patterson or "The Quants" by Patterson- Amazon will also show other similar books that readers "liked" in same category. You can probably get a copy at a local library- it's mind blowing stuff as to how brutal Wall St really is behind the scenes and what has evolved into this "electronic trading and hedge fund/blind pool" stuff and what it's done to distort the markets. As in how can/does say someone like an "Asher" often do what they do- as in going short a bunch on convertible shares, often being able to crush a stock price to dirt- all for their own fun and pure profit and personal gain, with "little guys" never having a chance or knowing what truck just ran um over.
An interesting guy to read and listen to his commentary on all this is the BILLIONAIRE ole Mark Cuban- who made his fortune on internet companies, now owns the Dallas Mavericks among other ventures and is on Shark Tank the TV show- he openly HATES this electronic trading, HFT high frequency stuff and thinks it's the bane of the markets now- destroying the original purpose of the public capital markets, who's original intent was to help aspiring companies raise needed cash, allow real investors a chance, etc. Not to allow a bunch of boiler room dudes who use MIT math geeks using some of the most sophisticated computer networks on earch to shave pennies off of trades, or "head fake" orders to drive stocks down in a blink, or crush entire companies in short plays and so forth. He's written some real good stuff on all this.
Just interesting you asked about ARCA and who they are as they are popping up with BHRT order flow - and then this HFT/private trading network article pops in today- might be a good read you'd be interested in.
I am almost certain ARCA or Archipelago would be the Archipelago Exchange/network. It's one of many, private "networks" where "big boys" can use/send order flow to match a buyer and seller. So it could be a place where the broker/dealer or an Asher like firm is sending some big order flow to get a "match" and make a sale. Those networks are very hard to decipher. Read up on "dark pools" and the like- those private ECN (electronic exchanges) are used a lot of time to make sales for a big client who doesn't want to be identified. Or, it can just be firm XYZ who wants to sell or buy and happens to be a member of that electronic trading network- and can use it to route order flow over to look for a "match". Hard to say. Are you seeing what looks like big selling or share volume stacking up on it? That would maybe indicate someone trying to move a large chunk for a big boy. Also, these broker/dealers have an entire bag of brutal tricks they use (think Asher) where they can "flash" orders up on these networks to get panic selling going, or go short, then they pull that order away- never intending for it to even fill, then "flash" it out their again to mislead people that a big sell is sitting out there- there's all kinds of games/shinanigans that go on. Hard to say just by seeing the broker/dealer symbol or network symbol like ARCA. Some of the real "boiler room" broker-dealer otc/pink symbols are notorious and real well known and tend to be a bad sign when you see them roll into view. But ARCA as far as I know - is someone using that network to route some order flow. Google ARCA, Archipelago network. I will say- it's a well known network for hedge funds and big, private trading firms to use, that's pretty well established- what their motive is in this case and are they buying or selling a chunk for someone can be real hard to decipher with what us "little guys" can see/know.
Agree. The 10-K can only include new things from the past 3 months, ending on Dec 30, 2013. All 10-Q and 10-K are essentially back-ward looking for a 3 month period and take a few months to compile and release- so recent events aren't even in them (sometimes little updates are amended at bottom- but for the most part they cover that 3 month, past tense period). And the 10-K is sorta the grand, yr end compilation and summary of all the yr's 10-Q's rolled up into the final, end of yr last 10-Q plus a summary of the entire yr as mgt sees it.
So yes, you can't expect it to reflect instant results for some PR news event, say released, one month ago- that's too soon usually to be put in this qtr's info and make it in the 10-K covering to end of last yr.
That balance sheet analysis was only to try and show what my estimated (and I think I'm pretty close- it's not a certified CPA analysis by any means, but just a look at the numbers they put out and some simple math)- but it was to try and show what is classically known as your "burn-rate" or cold, hard cash needs.
To try and give some idea how much money, actual cash, they need as a business to show up, pay people, keep the door open and lights on, and most importantly service their debt- that's the big one to me, as it's the one that can get you shut down, put in default if you can't pay it.
As you can see- the amounts aren't trivial. Needing about $250K a month coming in for operating the biz, and maybe as much as another $50K a month to pay interest and service the debt is a sizable chunk of change- and that is what Mike (he's the guy primarily in that hot seat each month) that's the reality he has to face and juggle each month- or it's lights out.
When you look at the share outstanding increases from about the past qty-3 10-Q's, the number of shares sold off to raise cash is not out of line at all with that $250K to $300K a month number. When you figure the stock then was only about 1 penny sometimes to maybe 2 or 3 pennies and they have to offer Asher and others a discount on the shares too boot- you can see that they could easily have needed to give up 100 million shares to "pay the bills". Example: 100 million shares at say .02 (BHRT's portion say after discounting to an Asher like firm)- that would bring in 100 million x .02 per share = about $2 million dollars, which just about jives with that 9 month usage of about $250K X 9 months or about $2 million to keep everything going.
So they need cash, and they need it on a continual basis. Those ventures and deals announced are more than likely an attempt to "try" and start to stave off that cash-burn need, but IMO will take time, a fair amount of time to ramp up to generating a couple $million a yr. In the mean time, if they need to keep seeing Asher and similar, I'd expect periods where, as we saw before, the stock can get hammered pretty hard when those "big boys" decide to unload a chunk of their shares, or worse, go short on the other side of their trade- which is their "style/known tactic" to get themselves even more money. There are detailed, well written articles about Asher and the like- they are brutal dudes. They don't lend wanting to make 5% or 12% return like your bad credit car loan place. They aren't happy till they make like 25% return or more in ea deal. High risk, high return and they're very good at what they do. Why does BHRT and other companies use them then? Well, sometimes you're just in the squeeze and hurt locker for cash- so you bite the bullet and do what you gotta do while hoping your other plans pan out and work out.
I'm still concerned can they really get the FDA level trial stuff really moving. It takes a lot of money- as in a LOT. When you go back a while- BHRT seemed to have a singular, very clear message that moving to an FDA trial completion was their total end game- and obviously to anyone owning, thinking of owning the stock- that was where everyone knew the mega big return or payoff would be. My concern is, they seem to be drifting off that focus and message into a lot of different "stuff"- just my opinion. It may be that they're just tight for cash and moving a 100 plus person trial ahead is a big cash user. But not hearing about Mirror and not seeing it the primary, main focus and instead seeming to shift almost to a new, "medical tourism" or some sort of hybrid company offering "treatments" around the world- struck me as odd and a little off-message/disappointing. You look back and read for yourself- you can kinda "feel" when all the news and updates and PR seemed to shift from FDA trial, FDA trial, FDA approval to now lots of other things being talked about, batted around- which also has to take the time of the chief science officer and others away from the trial(s).
Look at the other question posted that mentions the Baxter trial- that will give an idea what they face in terms of the 10,000 lb gorilla in the room. Baxter can toss a $100 mil down a drain, this instant, and it's a rounding error on their balance sheet- and they have 60,000 plus employees to use to do whatever they want to do. That's what BHRT is up against.
So yes, the game is "tight" and they're in a competitive, tough field to play in. And that month to month or qrt to qrt cash is the lifeline. Remember- Northstar was formed and had to step in as BHRT did go into default on a key loan (I think the Bank Of America loan) - which means they came really, really close to BK. Luckily some of the insiders stepped up to the plate and must of put up some kind of collateral- my guess, their homes/businesses, personal savings, etc to guarantee and extend that loan from being "called in" and putting the lights out on BHRT. One of the 10-Q's explains it in detail- that the key loan did go default and Northstar "assumed" it- which to me, is language that they stepped in and "guaranteed it personally".
So be reasonable on the 10-K, yes. I think you will still see a fair amount of new shares have been issued, increasing the outstanding share count a lot and I wouldn't be surprised that cash would be low again and tight. All just an opinion, educated guess- but that's based on the past yr of 10-Q's and other info.
I agree- building up expectations way to high, adds to the violent price swings and can cause a big sell-off when the story doesn't come up instant roses when they put out the real details- which is always the SEC document. Good luck.
The phase III you are referring to is a BAXTER TRIAL. It's clearly stated on the Temple web site and on Baxter's site.
http://www.templehealth.org/content/news.htm?page_id=7&minor=2&inCtx5pg=0&inCtx5news_id=236&inCtx5news=2&site_id=1&inCtx5order_by=S:%5Bstart_date%5D%20desc&major=4&inCtx5view=35
Note the disclosure, bottom of Temple page: "Editor's note: Neither Dr. George nor Dr. Houser has any financial interest in Baxter Healthcare Corporation."
He doesn't give a BAXTER disclosure because the trial is for BHRT??
http://www.baxter.com/press_room/press_releases/2012/02_28_12_stem_cell_cmi.html
It's pretty cut n dry. Has ZIP to do with BHRT and is not even the same technology- it's bone marrow derived cells. All explained in the links above. And no- the researcher is not under some "mystery" name- he's listed all over these PR's and it's FOR BAXTER and THEIR TRIAL.
"Trading in $BHRT shares = easy cash to bank almost daily, got it?" Don't have any idea what FACTS exist to even remotely back up such a statement? In less than a week you have bag-holders underwater as much as 25% or more, getting in at .08, some down 50% only a few days ago. Further, for about the past 2 yrs, the stock was STRAIGHT DOWN or at best a "saw tooth wave" oscillating between about 2 pennies to 1 penny and going nowhere- with a large number of bag holders stuck in at .04 or above from the last "event" that spiked the price (similar to this past 1 week or so) and then collapsed it nearly as fast- never to recover for over 1 to 2 yrs. So "easy cash" is not based in any facts that I think can be proven? And "cash daily" is even more of a stretch- today being a perfect example. Anyone buying in the AM got buried down hard, by close of market. Statements of gross generalities are amusing, for sure. I guess that's why most, probably 85% or more of "traders" lose money on a consistent basis, many go full on broke- those are well researched, well documented market facts. Not even debatable- backed by academia research, market research by every major brokerage house, etc. There's no such thing as an "easy money to bank" anything- if there was, everyone on this planet would be filthy wealthy. Pull up a 5 yr chart of BHRT and a 2 yr chart- and "try" and make the case it's "an easy money in the bank" anything? It's a loss making machine. Right now, it's down about 98.70 or more percent from it's IPO. That might be a new record of some sort- except for those gone BK.
Will do. I plan to give it a good read, cover to cover. If there is revenue in there, will try and find it and see what impact it would have on starting to be able to off-set the present burn rate. Cash is KING as they say in biz. You gotta keep it coming in the door one way or another - the lifeblood of any biz endeavor. As a small business man for example, you can't open so much as a small dry cleaner w/o knowing exactly what you need coming in each month to pay the basic overhead, hopefully pay yourself a salary, etc. I know a lot of small biz guys in my neck of the woods- and I can tell you one thing for certain, they know TO THE DOLLAR pretty much, what they need each day or month on average coming in to remain solvent or else they don't pay themselves or cut their guy's hours on their crew or whatever. I'm sure Mike knows pretty much to the dollar what it takes to keep BHRT open and running right now. That to me is the pickle they're in- cash coming in, versus trying to "work" the biz and make progress. 10-K will be a good update since the 3 months of that last 10-Q. I did note- the 9 months 2013, versus the 9 months 2012 has gone up a bit (they always list prior yr along side current yr in a balance sheet)- and that jives/is consistent with what we know- that they added a few staff, they undertook things like the Angel trial, so the spending going up a bit yr over yr is right in line and expected. We'll see what's next.
How much would BHRT need to be free of dilution/share selling? Also, how lopsided is their SG&A to R%D spending (my opinion)? There has been talk/speculation that perhaps BHRT could generate cash and be able to stop selling shares to the likes of Asher and others for what essentially amounts to survival cash, continual/on-going. So I looked at the last 10-Q balance sheet numbers- just looking at cash used for overhead (SG&A) and R&D (lets forget interest on their debt for now- but that adds even more to their cash needs).
To be free of needing outside cash via selling shares, what would they need? Well from last 10-Q period ending Sept. 30, 2013 they had the following cash use entries on the balance sheet (essentially no sales or cash source from biz activities)- which, again excluding even interest costs, will allow the "burn rate/cash need rate" to be approximated pretty easily.
From 10-Q balance sheet:
For the 9 months ended Sept 30, 2013 Marketing, General Admin costs were $1,750.276.
For the 9 months ended Sept 30, 2013 R&D (think trials) was only $494,762
So they consumed $1,750,276 + $494,762 = $2,245,038 CASH in 9 months
That would make the burn rate about $2,245,000/9 = approx. $250K per month. THAT IS WHAT THEY NEED MINIMUM COMING IN A MONTH to be free of outside share sales/dumping, etc and remain solvent, w/o laying off people, cutting current spending,etc. And that's on the low side as is does not include interest expenses on their debt.
So any/all these 3rd world biz undertakings, PR news of "deals", etc would need to generate at least $250K a MONTH coming in direct to BHRT at this burn rate to even get close to breaking even. There has been speculation that this could happen "soon"- personally I see it as a long shot, no way I can see anything recently announced getting them this kind of coin coming in this quickly, my opinion.
To give an idea of interest expense on the debt: Under supplement to cash flow activities page on balance sheet- they list interest paid on debt, for 9 month period ended Sept,30 2013 as $513,986 (just a bit higher than amount paid in same period 2012- so it's consistent).
That amounts to $513,986/9 = $57K PER MONTH.
That would bring the MINIMUM MONTHLY CASH NEEDS TO approx $300K PER MONTH just to break even and remain solvent, out of BK by paying their interest due, etc $300 THOUSAND A MONTH. That's about the magic number at this point per the documents- else you have to cut costs somewhere, get someone to allow you to delay paying interest- or you're insolvent pretty much.
What's also interesting is how little they spend on R&D in ratio to SG&A (salaries on 4 or 5 people, rent, general overhead, etc)- it's pretty out of whack in my opinion. A typical R&D to General Expense ratio of a healthy biz - giving some examples:
Lowe (a researcher) found that Merck ($MRK) spends 27% of its revenue on SG&A and 17.3% on research and development. Pfizer's ($PFE) ratio is even more lopsided, with 33% on SG&A and 14.2% on R&D. Smaller, more biotech-focused companies have better numbers; Biogen Idec, for one, spends 23% of its revenue on SG&A and 24% on R&D. That's partly because--we suspect--specialty drugs don't require the armies of sales reps sent out to support primary-care meds.
By contrast- of the approx budget for that 9 month period, BHRT spent about $1,750,276/2,245,038 = approx 78% ON SG%A (SEVENTY EIGHT PERCENT- to pay themselves, pay rent on a small office, etc. Just seems way out of whack to me- but that my 2 cents)
And about only $494,762/2,245,038 = approx only 22% on R&D
(Again, that doesn't include the additional $50K, a big chunk, they spend on debt service (interest) each month)- but it shows they don't spend much of what they generate/take in, in cash on R%D which is the "trials" and all. I don't see how you can possibly get a phase III, FDA quality trial through to completion on anywhere near that low an R&D budget, let alone fund the people needed for all the functions that will be needed- a massive report/data compilation effort, possibly more trials if the FDA demands more, etc.
Those are the cold, hard numbers from my read of the 10-Q (most recent) and the balance sheets, where the money goes, etc. I just don't see them getting anywhere near being free of selling more shares on a continual basis at this point and I don't see how you'd fund a large, FDA quality, phase III trial with those numbers above- I just don't see getting from point A to B in my opinion. It's not unusual in the slightest, to spend $10's of MILLIONS on a phase III, even exceeding $100 MILLION would not bat an eyebrow in the pharma-biomed world.
That's my take financially at this point. Looking forward to the 10-K. Owe, and the cash balance at the end of those numbers above was only $6K approx. total cash left on the books. 10-K should be interesting to say the least- looking forward to seeing what it says.
After hours are not always what they appear. A lot of time they are "clean up" trades being painted from throughout the day. It's tricky to interpret after hours a lot of the time. I'm not even sure on the rules of the pink/otc for trading after hours- I'd have to look into it. But again, sometimes they are trades clearing from earlier in the day- that much I know is typical a lot of the time.
Finished at .0562 eeking out a 2% gain on high volume. Someone sold into that strength. One big dip after initial AM pop, then closing out back at that same point, or close to it.
20% swing in a single trading day doesn't seem anything like "normal" or "healthy" trading to me? Further, this was taken to .08 in a blink (less than a 24 hour trading period), then cut by very close to 50% almost as fast- again, not a normal trading pattern or activity in my book. On a listed or big board stock, that would trigger an investigation almost for sure. This thing is in what I call yank-n-bank trading to say the least. You have people buying in the AM, then underwater 20% or more by end of day, WOW. Interesting to see what happens from here- someone sure sold hard into the AM strength today. I don't think that was just little ole retail orders on that volume. They put out a LOT of options, insider shares, debt-to-equity shares and so forth in just the past several months (in addition to probably finance house shares and convertibles)- so, could be a lot of shares wanting to sell into a strength point. We'll see I guess.
And WHO/WHAT is "Magnum" other than apparently a web site and a 6th floor office building location. Nothing on their web site even lists how many doctors/physicians they have, a look at their facilities, any other salient detail are missing in typical BHRT PR fashion: there is zero reporting of what Magnum's revenues were, say last yr, how many employees they have, are they profitable, how many stem cell "procedures" they have ever performed, how are they capitalized, their valuation estimate (as BHRT took 10% ownership- but in what, who knows?), etc. From an investment stand point, that PR said pretty much nothing. Nothing that can be verified as to its effect on BHRT in terms of revenue, or cash flow, or sales, or anything else of that nature. A more "vague" PR I don't think can be written from an investor's point of view. Generalities. That's what I read. I searched "Magnum Stem Cell" exhaustively in Google and get nothing. Nothing but today's BHRT pr and the Magnum web site- which doesn't say much, that much is for certain- it's about as plain-jane as they come IMHO.
NO NEWS- no new revenue announced, no imminent possibility of significant revenue(s) even implied, they already are in a supposed Phase II/III that has gone nowhere so a FIVE person "trial" in Mexico (not U. Miami as originally "claimed" in the original PR) is a non-event, they are dumping shares by the 10's millions to keep survival cash coming in, they have diluted the common by an enormous amount in a very short period of time, etc, etc. Everything you posted there is noise level and in no way explains a ONE DAY, 24 hour period quadrupling in price, followed by a 50% dump in price within 48 hours- no way, no how, not even close. It takes a lot more than that "stuff" you posted to explain how the price went berserk and the volume too- no normal stock trades like that. On a listed or "big board" stock- it would almost certainly trigger an automatic investigation. Nice try though. Really.
Well, when they gave um the shares at less than 2 cents and say, somehow the stock just gets blown up from .02 or so to .08 in about a 24 hour trading day on no news of any merit or real substance- um, try putting the puzzle pieces together? You really "think" any stock trades like that under "normal" trading behavior or patterns- especially with a float as large as this? Please. A quadruple in price preceded by "tweet blasts" and chat boards suddenly posting 100 or more messages a day after being nearly silent for months? Really? Not the way I see it. To each his own. I know what I call a price run and subsequent 50% of greater price collapse like this just had. It's common in penny-land.
"BioHeart are a leading company amidst a paradigm shift in medicine. "?? I find the statement that ANY company trading at sub 5 PENNIES, with essentially no cash at any given moment, 4 to 5 employees in a small, rented "suite", etc is a "leading" anything and certainly not behind or the driving force of any "paradigm shift in medicine"? What a vapid, imaginary based statement with no facts to back it up whatsoever. They trade at sub 5 pennies and a micro, micro market cap for a reason. You figure it out.
If the majority of any of the things you mentioned had already actually "happened" - you'd have already seen them in an official PR. Companies can not "sit" on key, material event "news" such as financing relationships, key deals, etc. So no, I don't expect anything new other than more dilution, very little cash on the balance sheet entry, a near word for word copy of past 10-Q/10-K docs which has been the norm for about 2 yrs now, etc. Nothing "new" expected IMO. I'll look for a) the share count page 1 then b) read the balance sheet with the cash line, line one being the first thing I look at. Then, I'll go down to the details in the "financing" section and do a search for the words "note" and "convertible", etc. I'll look for the "Mirror" section, and if it's as last report- it barely got a passing mention and had no updated info. I don't expect much difference now- if they had key enrollment metrics, they would have already released them. I'll then search for all the other PR "deals" released over the past 6 months or so, and if it's SOP, I don't even expect to find them mentioned or very little to be said about them. That's about it in a nut shell.
Who "finances" BHRT EXPLAINED: here is a I-HUB page someone else built that gives a very good insight/explanation into what it's like to "do business" with Asher, just one of several "desperation financing" firms that is littered all throughout the BHRT 10-Q/10-K's of at least the past 2 yrs or more. I gave many references a few posts back, as to how many times BHRT has used them in just the past 2 yrs- all taken direct from the BHRT 10-Q/10-K documents.
This I-HUB page the other poster built explains very well why doing business with firms like this are so "toxic".
http://investorshub.advfn.com/~-ASHER-~-25451/
It's called the "Asher board" and it's right here on I-HUB. READ IT if you want to know who is "shorting" BHRT and why.
Examples of WHO WOULD BE "short" BHRT and how desperate their financial situation really is. Lets cut the hype and go to the facts, the SEC documents. I've just cut n pasted a "sampling" - it'd take hours to get all the info as it is pages long. But when you see "convertible" - think "shorting the stock" by that person providing the "financing". 2) Look at how desperate the terms of the financing are (steep share discounts) and for what a pittance of cash they bring in- $20K to less than $100K typically- survival money on a month to month basis esentially, as the cash balance line in each of those same 10-Q/10-K will show cash near zero each time. 3) Each report also contained a "going concern" letter from the auditor, as the cash trickling in from these deals is barely enough to service the debt, let alone supposedly be conducting vast "trials" and world wide operations, paying their salaries of 4 or so employees, rent, etc. This is just a sampling, all taken from the company's own SEC filings. Want to moan and groan about "shorting"- then read the names in these "financing" deals- cause they are the ones incentivized to be short the stock and they have the means to do it- being professional firms, some of them very well known on the street as "financiers of LAST RESORT" for company's on life support. What you will note is a pattern of POURING OUT SHARES BY THE MILLIONS LIKE WATER- thus the massive dilution that is easily noted by looking at the ever increasing share count with each passing 10-Q/10-K:
10-K Dec 31, 2011
As of March 26, 2012, we had cash and cash equivalents of approximately $1,700 (yep, that ONE THOUSAND, SEVEN HUNDRED BUCKS TOTAL- for a public traded company, AMAZING) and a working capital deficit of approximately $12.3 million. As such, our existing cash resources are insufficient to finance even our immediate operations.
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.
The loans evidenced by the New Magna Convertible Note are in the nature of convertible debt evidenced by two unsecured convertible promissory notes, each bearing interest at the rate of 8% per annum, payable at maturity and each convertible into common stock of the Company at a price that is 50% less than the average of the closing prices for the Company’s shares for the five (5) days prior to the Lenders’ election to exercise its conversion right.
• In January 2011, the Company issued an aggregate of 538,542 shares of our common stock in connection with the conversion of $87,729 of the convertible note.
• In February 2011, the Company issued an aggregate of 421,392 shares of our common stock in connection with the conversion of the remaining balance of $52,000 of the convertible note.
10-K, Dec 31st, 2012
Unsecured Convertible Promissory Note for $63,000, with Asher Enterprises, Inc. dated April 2, 2012
Unsecured Convertible Promissory Note for $125,000, with IBC Funds, LLC, dated January 10, 2013
Unsecured Convertible Promissory Note for $42,500, with Asher Enterprises, Inc. dated January 23, 2013
Unsecured Convertible Promissory Note for $37,500, with Asher Enterprises, Inc. dated February 27, 2013
10-Q March 31st, 2013
On January 9, 2013, the Company issued an unsecured promissory note and 2,500,000 shares of common stock with IBC Funds LLC. (“IBC”) in the principal amount of $125,000 (the “Note”).
The Note is convertible into common stock, at IBC’s option, at a 60% DISCOUNT to the average of the three lowest closing prices of the common stock during the 5 trading day period prior to conversion.
During the three months ended March 31, 2013, the Company entered into a Securities Purchase Agreements with Asher Enterprises, Inc. (“Asher”), for the sale of an 8% convertible notes in aggregate principal amount of $80,000 (the “Note”).
The Notes bear interest at the rate of 8% per annum. All interest and principal must be repaid between September 11, 2013 and November 22, 2013. The Notes are convertible into common stock, at Asher’s option, at a 42% DISCOUNT to the average of the three lowest closing bid prices
On February 4, 2013, the Company amended its Articles of Incorporation to increase the number of authorized shares to 970,000,000, consisting of 20,000,000 $0.001 par value preferred stock and 950,000,000 $0.001 common stock.
During the three months ended March 31, 2013, the Company issued an aggregate of 4,933,891 share of its common stock for settlement of $72,339 of accounts payable. In connection with the settlement, the Company recorded a loss on settlement of debt of $74,401.
During the three months ended March 31, 2013, the Company issued 2,500,000 shares of its common stock in connection with the issuance of a note payable.
During the three months ended March 31, 2013, the Company issued 1,000,000 shares of its common stock in connection with the settlement of a note payable.
10-Q June 30th, 2013
During the six months ended June 30, 2013, the Company entered into a Securities Purchase Agreements with Asher Enterprises, Inc. (“Asher”), for the sale of 8% convertible notes in aggregate principal amount of $112,500 (the “Asher Notes”).
4. The Notes are convertible into common stock, at Asher’s option, at a 42% to 45% discount to the average of the three lowest closing bid prices
10-Q Sept 30th, 2013
Cash and cash equivalents : $6,684.00 DOLLARS.
During the nine months ended September 30, 2013, the Company entered into a Securities Purchase Agreements with Asher Enterprises, Inc. (“Asher”), for the sale of 8% convertible notes in aggregate principal amount of $170,000 (the “Asher Notes”).
The Asher Notes bear interest at the rate of 8% per annum. As of the quarter ended September 30, 2013 all interest and principal must be repaid nine months from the issuance date, the last note due June 11, 2014. The Notes are convertible into common stock, at Asher’s option, at a 42% to 45% discount to the average
On August 1, 2013, advances in aggregate of $22,750 were converted into a demand promissory note with 5% interest per annum. On September 30, 2013, the Company issued 1,995,614 shares of common stock in settlement of the $22,750 promissory note.
On September 30, 2013, the Company issued 8,771,929 shares of its common stock as payment of $100,000 towards cash advances.
On November 2, 2011, the Company and Greystone Capital Partners (“Greystone”) entered into a Standby Equity Distribution Agreement (the “Agreement”). Pursuant to the Agreement, Greystone has agreed to provide the Company with up to $1,000,000 of funding for the 24-month period following the date a registration statement of the Company’s common stock is declared effective by the SEC (the “Equity Line”).
During this 24-month period, commencing on the date on which the SEC first declared the registration statement effective, the Company may request a draw down under the Equity Line by which the Company would sell shares of its common stock to Greystone, which is obligated to purchase the shares under the Agreement.
For each share of the Company common stock purchased under the Agreement, Greystone will pay eighty percent (80%) of the average of the lowest daily volume weighted average price for five consecutive trading days immediately preceding Advance Notice (the "Valuation Period") commencing the date an Advance Notice (the "Advance Notice") is delivered to Greystone in a manner provided by the Agreement. Subject to certain limitations and floor price reductions, the Company may, at its sole discretion, issue a Put Notice to Greystone and Greystone will then be irrevocably bound to acquire such shares. The registration statement of the Company's common stock pursuant to the Agreement was declared effective on February 10, 2012 and a Post-Effective Amendment was declared effective on May 7, 2013. On December 1, 2012, the parties to the Equity Line agreed that the Purchase Price be adjusted to seventy-five percent (75%) of the lowest daily volume weighted average price of the Common Stock as quoted by Bloomberg, LP, during the five (5) consecutive Trading Days (as such term is defined in the Equity Line) immediately subsequent to the date of the relevant Advance Notice.
During the nine months ended September 30, 2013, the Company issued an aggregate of 12,658,545 shares of its common stock in exchange for $200,000 draw down on the equity line.
1) There is NO, NONE "shorting" of a 4.5 penny stock by any retail investor. PERIOD. End of story. The only people "shorting" this stock are involved in providing "financing" to BHRT. They get "convertible notes" along with steeply discounted shares in exchange for providing cash to BHRT. Those convertibles are thee incentive for them to short the stock to get more shares, and cover at a greater profit. There is never "shorting" by retail investors of stocks generally under $5. Call any broker/brokerage house you want and prove me wrong. The ONLY "crony" friends as you call them (your made up words) are the people who BHRT WILLINGLY GOES TO, off free will to get survival cash to keep their doors open (Asher, Gray and about a half dozen other well known "finance houses of last resort" on the street. Anyone familiar with penny stocks in desperate straights knows all the names and they are in every 10-Q BHRT put out, if you would just take time to actually read them.
2) There is no "mm" in the OTC/pink sheet markets. There are broker/dealers who are subscribers to a variety of trading networks and licensed to handle order flow in the OTC/pink penny markets. So you are using a 100% incorrect term.
3) Pull up a simple, 2/3 yr chart- say Jan 2011 to today, and you'll see this pattern of pumping and dumping is nothing new. It's a very repeated pattern in this penny. It's now been whacked in half from the .08 peak, and all the past, similar "events" did the exact same, then drifted back to .02 or even lower in the coming month. The volume dropped off sharply with each passing day from the peak- yesterday being the lowest, meaning the mo-mo pump play is over IMHO. Nothing new here occurring. Just same old, same old for this penny play.
347 Million is a LAGGING number- it's gonna be a lot more than that today. That's from the last 10-Q. They dilute in massive quantities to keep their survival cash coming in- it, for the most part, is the only source of cash they have.
As of November ____, 2013, there were 347,175,310 outstanding shares of the Registrant’s common stock, par value $0.001 per share.
As of August 6, 2013, there were 236,657,436 outstanding shares of the Registrant’s common stock, par value $0.001 per share.
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 about 7 months or so, they diluted from 200 million outstanding to 347 million out- a staggering dilution in that short a period of time. Remember, the April 30, 2013 date was when they blew through their outstanding allocated per their charter, so they just amended it and chose a HUGE number of almost 1 BILLION shares, I believe about 950 million or so. Why do you think they'd pick such a staggeringly high number? Cause they knew just to survive a yr, maybe a yr and a have they'd be pouring out shares like water and blow on past 500 million or so w/o even trying hard.
This coming 10-K, page 1 will have the number. If you look at that trend above, they're easily going to be past 400 million shares, I think well past- as in at least 425 million minimum. The common holder has been for the most part diluted down to toilet paper status. Further, they, via the stroke of a pen- redid the Northstar preferred shares to insure that Northstar, even if the 950 million share count or whatever is reached, always controls the shareholder vote. Their preferred shares get like 20 or 25 votes to every common. So the common shareholder in this company has ZERO "rights", none. Nothing ever could, or ever will be put to a vote of the shareholders (common) as there would be no point to it. They've essentially handed the entire company over to Northstar- they pretty much own/control it all, all for a loan of about $600K dollars. Not a bad gig if you can get it.
Andy, it's certainly true the broader markets took it pretty heavy on the chin today. What I find interesting when following BHRT- is that it usually has no relation to what the broader markets, or even other stock segments are doing (bio, pharma for example). BHRT seems to always just "dance to it's own tune". Market has a huge rally for months or a big up day and BHRT goes down or down big. Market has a terrible day- and there's ole BHRT all the sudden trading strong for several days. I've never found a correlation on this one? It's a sorta lone wolf out there usually IMO.
My opinion- volume has dried up sharply indicating the pump is over. Expect lower highs and lower lows from here as it drifts down. A single significant sell order can sink it 20% or more in one fell swoop as we've seen many times in the past, and in just the past few days.
All down hill from here, IMO. 2 cents is where it's "naturally" attracted to. But hey, as of today- the market cap is just about equal to the debt so the company is now valued at about zero, as opposed to negative. Not bad.