What’s the deal with US Stem Cell Inc stock?

The stem cell clinic business US Stem Cell Inc., formerly known as Bioheart, has seen its stock take a rollercoaster ride recently include a big run up and now today a big drop so what’s the scoop?

US Stem Cell, which includes a few subsidiaries such as US Stem Cell Clinic, focuses on the use of adipose stem cells to treat a variety of health conditions in people, as well as training and pet treatments.

US Stem Cell Inc Stock USRM

To my knowledge, the company does not have FDA approval such as an IND for the stem cell interventions that it sells. In addition, there is some debate over whether adipose stem cells/stromal vascular fraction is a biological drug. As a stem cell scientist and close follower of the field, I believe it is a drug. Note that I’m not aware of the FDA having taken any action on US Stem Cell or its competitors who use adipose stem cells. The company has also recently settled two patient lawsuits, which included allegations of harm to vision by a number of entities.

On the potential upside for investors, it seems there remains strong demand across the US and the world amongst patients for what stem cells clinics are offering even without FDA approval.

Why is the US Stem Cell Inc stock moving so much recently?

It looks like an investment research firm put out a report on the company and the report apparently details the company making deals outside the U.S. and in the Middle East so this may be part of what is driving the stock to move around.

There also seems to be something recent about a lawsuit settlement on social media, but seems pretty vague so hard to say if it is accurate or means something.

Any other thoughts?

Disclosure: I have no investment in stem cell/regenerative medicine stocks including US Stem Cell or its competitors.

What is your favorite stem cell/regen med biotech & why?

stem cell stocksI’m putting together a list of stem cell and regenerative medicine biotech companies for a blog post, including both public and private. I’ve got a good list already, but want it to be fairly comprehensive.

I’m also curious what readers think are the most promising ones and why. So weigh in with comments please or email me. Ideally, you would indicate if you have an investment in these stocks for the publicly-traded ones. Don’t restrict yourself only to stocks traded on US markets necessarily and private companies like ViaCyte are exciting as well so should be included.

It’s also interest to see how these lists change over time reflecting shifts and trends in the industry. For instance, Ocala (fka as ACT) is gone. StemCells, Inc. is gone. CDI is gone as an independent entity at least.

Look for a future post with a stem cell/regenerative medicine biotech list. If you invest in this sector be aware it is extremely risky and over the years most of these kinds of stocks have tended to go down more than up.

Top 10 reasons for optimism on Stem Cell Awareness Day 2016

Happy Stem Cell Day!

It is a tumultuous time for the stem cell and regenerative medicine fields, but despite this there are concrete reasons for optimism on this Stem Cell Awareness Day. I’ve listed my top 10 below. What else gives you a sense of optimism? You can also check out CIRM’s nifty stem cell awareness day page too, from which I borrowed the below image.stem-cell-awareness-day-2016

  1. More trials = road to progress. There are more real, robust clinical trials than ever and they are progressing past the early phases in some cases. The trials are piling up and while not all will succeed, some will. Keep an eye open for the for-profit, non-FDA-approved ones and steer people away from those.
  2. We are seeing a flow of clinical trial data too pointing to encouraging outcomes, but also to challenges to overcome (witness the preclinical study on IPSC for heart attacks that found efficacy but also arrhythmias). With that kind of awareness such hurdles can be overcome in many cases as the work progresses.
  3. The FDA held public meetings on stem cells. We can grouch about certain things about these meetings and we can ding the FDA for various issues, but it never before has engaged with the community like this on stem cells so it’s a good thing.
  4. Stem cells firing on all cylinders: adult and pluripotent. Adult stem cell trials are building, but so now are pluripotent ones. The best way to help the most people in the long run is with all the tools (types of cells) we can utilize. The notion of “adult versus embryonic”, for instance, as some sort of cosmic battle seems out of date. We need both and also IPSC as well as other types as yet to come.
  5. The stem cell clinic problem out in the open. Never before has there been this much information and awareness out there on the problem of stem cell clinics taking advantage of vulnerable people. For instance, see my recent article with Leigh Turner and the one from John Rasko’s group. I believe awareness will translate into action for the positive.
  6. Putting the fun back in funding? NIH funding trends are looking at least slightly better overall which will help with stem cell research. CIRM is continuing its life extension and will fund many more projects in years to come. Other states are funding stem cell research too. It’s still a bad time for funding but the trend lines are at least moving the right way.
  7. Much more educational outreach on stem cells. When I started blogging about stem cells in early 2010 it was very quiet out there on the Internet in terms of those of us trying to educate a wider community in a positive manner. That’s really changed now with quite a few blogs that at least touch on stem cells and a number entirely dedicated to stem cells and regenerative medicine. This is a positive change and it means the public has more resources than ever to learn about stem cells.
  8. IPSC clinically-relevant work is looking up. It was a decade ago that IPSC cells were “born” and there were great expectations. Now 10 years later there are tangible signs that these cells will have lasting, huge impact including both from disease modeling and more recently via potential future clinical use.
  9. Stem cells meet CRISPR and…boom! Okay so everyone is nuts about CRISPR no matter what kind of cells they study including me, but CRISPR-Cas9 gene editing combined with stem cells in particular equals great potential both for new insights such as into human development and also potentially clinically through designer stem cells.
  10. Stem cell biotechs & stocks hanging in there. It has always been tough going for stem cell biotechs and that is likely to continue quite a while longer, but many are hanging in there and could surprise you down the road. Others have been acquired by pharma companies or inked collaborative deals in the last year or so. In the long run some of these companies are going to change medicine.

New Stem Cell Stock Ticker

stem cell stock tickerI’ve added a fun and helpful new feature on the right side bar of the blog in the form of a stock ticker for some of the most widely held stem and cellular medicine companies. A sample screen shot is shown in this post.

Quite a few stem cell-related stocks could not be added to this ticker for various reasons including ACTC, Mesoblast, CUR, and others. Yahoo has limits on which stocks can be included based on company size and which exchange they are on.

Think I should have included a different panel of stem cell stocks? Let me know what you think.

 

Stem cell company Intellicell facing new financial wrinkles

IntellicellIt’s difficult to make it as a biotech company and I would say stem cell biotechs in general may have an even rougher time.

One such company,  Intellicell (Intellicell Biosciences, Inc), is showing a number of signs of distress in my opinion.

An online financial tool predicts the probability of companies going bankrupt within the next 24 months. For Intellicell it estimates a greater than 96% chance of bankruptcy. By comparison another stem cell biotech, Stem Cells Inc., has a less than 1% change of going bankrupt.

How accurate are such tools?

I don’t know, but in a general sense perhaps they can point to concerns about instability.

What’s up with Intellicell these days?

By way of background, in March of 2012 Intellicell received a warning letter from the FDA.

The letter, addressed to Intellicell CEO Dr. Steven Victor, indicated many concerns including more than minimal manipulation of the company’s stem cell product.

I’m not aware of any info indicating that Intellicell has resolved its issues with the FDA. (Intellicell, please fill us in on the status of this situation please!) Note that I have made several attempts to contact Intellicell for comment on their situation before posting this, but have not received any reply.

Intellicell has made a number of filings of events with the SEC recently including one about a week ago detailing (A) departure of an important leader, John Pavia (Senior VP) and (B) a possible eviction notice.

Further, a search of the New York State Supreme Court Records found 5 current or recent cases in which Intellicell is a defendant.

The plaintiffs include CRAGMOONT CAPITAL LLC, MARC J GOLDSTEIN LITIGATION &, EINWOHNER ETHAN, SHERB & CO LLP, and JKT CONSTRUCTION INC. They are asserting that Intellicell owes them money.

One plaintiff, JKT/Corcon construction, alone claims to be owed “$442,344.03” by Intellicell for services it provided.Dr LookGood Victor

Defendants in the cases include Intellicell, Dr. Victor, Angela Metelitsa (apparently Vice President of business administration at Intellicell), and Anna Rhodes Victor (Dr. Victor’s wife).

SEC filings indicate yet another case beyond the 5 above with a plaintiff “Menachem M. Bluming” seeking $680,000 in damages. Dr. Bluming appears to be another physician.

What does the future hold?

Of course in any legal case the defendants, for example Intellicell, Dr. Victor, and others here, are innocent unless proven otherwise. In addition, another reason not to count him (or Intellicell) out by any means is that Victor has persisted despite past lawsuits. For instance, New York Magazine did a feature on lawsuits against Victor way back in 2008 (see pic above from that piece).

Let’s see how the company navigates these waters in the coming months. I think there will be lessons for the stem cell field no matter how it goes.

Disclaimer: this post is not intended as financial advice.