PolarityTE: Investors Beware

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Summary: PolarityTE, Inc. (PTE)

  • PolarityTE’s sole key asset is a patent application that it acquired for a value of $104.7 million.
  • Common equity holders are exposed to severe potential dilution, given a capital structure that is saddled with convertibles.
  • PolarityTE has failed to release its full pre-clinical data, and its planned human trials appear delayed.
  • The entity has been reverse merged several times into a variety of businesses. We believe PolarityTE is the latest in a series of failed story stocks.
  • We believe the common equity is likely worthless.

PolarityTE Inc. (COOL), formerly Majesco Entertainment Inc., is a company that aims to “induce a paradigm shift” in the field of tissue engineering and regenerative medicine. The company was formed via reverse merger of PolarityTE into the publicly traded entity of Majesco, as announced in December 2016. Prior to the merger, Majesco had been focused on the unrelated field of video game publishing.

The public entity has managed to morph into at least 6 different seemingly unrelated companies over the years (Majesco was formerly Spinrocket, which was formerly Connectiv, which was formerly CDBeat, which was formerly SMD Group, according to its SEC page).

We believe PolarityTE is merely the latest iteration in a series of failed story stocks, and that common shareholders are exposed to severe risks.

Prior to its Merger with Majesco, PolarityTE Owned a Single Patent Application

Generally, when we see an entity reverse merge onto NASDAQ, the deal will include a reasonably strong pretense for the value generation potential of the company. Often such a pretense will include either physical assets or a strong intellectual property portfolio. In the case of COOL, it appears the Majesco entity had merged with Polarity in order to take a single, lonely patent application public.

The loneliness of the patent application (and the fact that it was merely an application) was not immediately clear to us from a reading of the filings. At various times, filings indicate that the merged Polarity entity owned a (i) “patented” platform; or (ii) multiple patent applications (as indicated by the “s” at the end of the word ‘applications’). This shape-shifting description is best shown through the December 2016 8-K announcing the merger in which both versions of the story were detailed in the same document:

  1. “Polarity is the owner of a novel regenerative medicine and tissue engineering platform developed and patented by Denver Lough, MD, PhD.
  2. Later in the filing, “Polarity’s pending patent applications include claims to material aspects of Polarity’s procedures that are not currently protected by issued patents. The patent application process can be time consuming and expensive.”

A search of the US Patent and Trademark Office (USPTO) database, and later filings show that neither description appeared to be accurate. Polarity was in fact the owner of a single patent application (without an ‘s’ at the end) filed by Dr. Denver Lough, a resident associated with John’s Hopkins University. Per the 10-Q dated April 30, 2017:

“Dr. Lough is the named inventor under a pending patent application for a novel regenerative medicine and tissue engineering platform filed in the United States and elsewhere. The Company believes that its future success depends significantly on its ability to protect its inventions and technology. Accordingly, the Company is seeking to acquire the pending patent application.”

In case there was any doubt about whether the merged business didn’t just consist of a mere pending patent application, an SEC correspondence letter requested that the company detail the operations of the entity being merged. The company responded by affirming that Polarity indeed had been functionally a shell with no employees, operations, or property other than the pending patent application:

“There was never any intent to acquire an ongoing business and no ongoing business was acquired. The asset is preserved in a stand-alone entity merely as a vehicle to provide the Company a seamless means to acquire the asset (a patent application) without undue cost, expense and time. Polarity NV has never had employees and therefore no employees will be acquired in the transaction.”

The company paid a substantial amount for the patent application. According to the company’s filings, the company paid to Dr. Lough preferred shares “convertible into an aggregate of 7,050,000 shares of the Company’s common stock with a fair value of approximately $104.7 million.” Note that those same shares would represent about $200 million if sold at today’s prices.

PolarityTE is a Share Dilution Machine

PolarityTE aims to revolutionize the skin regeneration market by developing and commercializing its intellectual property. We will get more into our thoughts on its chances of success shortly, but we first want to address what we view as a major hurdle for common shareholders hoping to benefit from the company’s efforts to achieve new medical breakthroughs.

Namely, COOL has been rapidly diluting shareholders, and the current capital structure seems to represent a massive wall of potential new dilution. Below is a breakdown of the common shares outstanding over the past several periods, based on company filings:

  • 09/12/20176,333,985 shares of common stock outstanding
  • 06/05/20175,876,952 shares of common stock outstanding
  • 03/08/20174,501,768 shares of common stock outstanding
  • 10/31/2016: 2,782,963 shares of common stock outstanding

For those keeping track at home, that is an increase of about 127% – more than double – in just over a year.

Beyond the ballooning number of common shares outstanding, as of 7/31/2017 common shares issuable upon conversion of preferred stock and exercise of stock options represents another potential 11,939,093 shares, a tripling of the existing cap structure.

Keep in mind that convertible holders have additional rights, including “the right to receive a liquidation preference, prior to any distribution of our assets to the holders of our Common Stock.” Convertible holders can also be paid dividends on an ‘as converted’ basis, so that dividends could be paid out as if preferred shares were fully converted to common. In other words, if the company distributes cash via a dividend or liquidation, the common holders could experience dilutive effects via those events as well.

How Are Things Coming Along So Far with the Skin Regeneration Revolution?

Dilutive share structure aside, the company seems to be advancing its technology at a rather uninspiring pace. In a press release on June 8th, the company announced that pre-clinical results demonstrate that the technology can successfully regenerate skin and hair in full thickness swine flu models. On a conference call following the release, CEO Denver Lough stated:

“The preclinical image based data released today is by no means even 1% of the data we have collected, which will be released in due course via peer reviewed articles and other public forums.”

We searched Google Scholar and ResearchGate for any peer reviewed articles on the company’s pre-clinical research and found zero articles since that release. We also found no subsequent data released by the company. We have asked investor relations whether the company has released its data and whether there are any peer reviewed articles on the data and have not heard back as of this writing. Should we hear back from the company, we will update this accordingly.

In that same June 8th press release, the company seemingly indicated that additional future milestones would be forthcoming:

“The Company expects to initiate a human clinical trial evaluating the autologous homologous SkinTE™ construct in the third quarter of 2017.”

There have been no human trials announced since that date. We checked clinicaltrials.gov to see if any trials had been posted and found zero matches.

October 19th Update Leaves Us Befuddled

Subsequent to the promises of the release of data and human clinical trials, on October 19th the company stated in a press release:

“Clinical application is expected in the fourth quarter of 2017, and data is planned to be released through multiple channels in the first half of 2018.”

Again, we haven’t seen the data or seen any registered clinical trials thus far. We checked with investor relations to get a sense of the expected timeline of human clinical trials, given that we are currently near the end of 2017. We have not heard back as of this writing, but should the company respond, we will update this accordingly.

The same release noted that “multiple value analysis committees have approved SkinTE for use in their respective medical institutions”, though the release did not name any of the institutions that had approved the product. It is unclear to us exactly what was “approved”, given that the product has not yet been tested in humans. After all, how can something be approved before it’s even been proven to work?

Again, we checked with investor relations to see if they could name any of the medical institutions that have approved the product or give a sense of what the approvals represent and have not heard back as of this writing. Should we hear from the company, we will update this accordingly.

Lots of PR With Few Tangible Results

Despite the apparent absence of released pre-clinical data or the commencement of clinical trials, we have noticed that the company has managed to generate a tremendous amount of PR via various media outlets. It has also issued about 25 press releases over the course of the past year, and assembled a clinical advisory board of over 14 medical professionals. Such loud moves with little hard data or tangible advancement to show for it do not inspire our confidence.

Conclusion: Not COOL!

The path to bringing the company’s lonely patent application through clinical testing and market entry is likely an expensive proposition. Even when factoring in the proceeds of yet another recent convertible offering the company’s estimated working capital of approximately $20 million seems to represent the mere beginning of what would require substantial additional capital.

We cannot claim to be experts in the field of regenerative skin medicine, and we truly hope the product ends up working in humans. Despite this, we do have a fairly thorough understanding of the effects of dilutive financing to common shareholders. On a fully diluted/converted/exercised basis and at current prices, the company’s market cap would be north of $500 million. We do not believe the company’s progress to date can justify that valuation no matter how many great scientists the company adds to its board of advisors.

Given all of the above, we believe common shares are likely worth pennies rather than dollars. We urge cautious investing to all.

Disclosure: I am/we are short COOL.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

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