Marker Therapeutics Inc (MRKR)

[jbem777]

TPIV DD- Information for New Investors

I have been watching this pick for a while, waiting for the right time and entry. I have taken a position at $.22 and see this making a nice move based on significant catalysts over the next few months. For those of you who have made money on AVXL and PTBI, this is the ultimate combination of the two. Very few outstanding shares, miniscule float, huge institutional ownership, outstanding warrants far above share price, recent financings (2) to large institutional investors, upcoming catalysts, partnerships with renown medical centers, and it has been all but been forgotten about by the market. Just a year ago, it was trading at over $7.

Tap Immune: TPIV

Company Presentation: http://www.tapimmune.com/wp-content/uploads/2014/02/Maidstone-NYC-03262015.pdf

Fully Reporting OTC

Outstanding shares: 32, 639,000

Page 14 from their most recent 10K
http://www.sec.gov/Archives/edgar/data/1094038/000142488415000039/form10-k.htm

Float: 5-14 million shares. See below for more info and breakdown.

Market Cap: $7.1 million

This is not a joke, according to the company, they have only 5 million shares in the float of 32 million shares total, and a MC of only $7.1 million. I will detail the numbers below, as there might be a larger float, but this is what is reported by the company in their Corporate One Pager.

http://www.tapimmune.com/wp-content/uploads/2014/02/TPIV-one-pager-03222015.pdf.

As a good trading buddy said “You could sell used underwear and have a market cap greater than $7 million.”

Ownership Summary:

Insider Ownership: 3.38%
Glynn Wilson, CEO 806,970
Mark Reddish, VP 229,500
Sherry Grisewood 28,329
1,064,799 shares

Institutional Ownership: 55% , but likely more

Empery Asset Master: 4,167,950 Shares
18,772,265 Warrants

http://www.sec.gov/Archives/edgar/data/1094038/000090266415000096/p15-0062sc13g.htm

Brio Capital Master Fund: 5,000,000 Shares
25,000,000 Warrants

Interestingly, there is not a 13G filed for BRIO, but the company’s most recent 10K identifies them as the holder of this many shares and warrants.

Eastern Capital Limited: 5,000,000 Shares
25 Million Warrants

http://www.sec.gov/Archives/edgar/data/1094038/000140840815000026/ecl_tpiv13d.htm

Iroquois Capital Management: 1,945,795 Shares
8,749,975 Warrants

http://www.sec.gov/Archives/edgar/data/1094038/000093041315001217/c80645_sc13g.htm

American Capital Management: 750,000 Shares
37,500,000 Warrants

http://www.sec.gov/Archives/edgar/data/1094038/000114420415016463/v404523_sc13g.htm

The sum of shares owned derived from the Form 13’s and the 10K comes to 17, 928, 544, which leaves a float greater than 5 million. So I am not sure where the estimate of 5 million shares comes from. Either way, the float on this stock is somewhere between 5-14 million or $2.8 million. That’s nothing for a stock trading at $.22.

The company has done a number of offering since August 2014 and most if not all the institutions listed above have been the only purchasers. That is the have bought more than once from the company and these purchases have been between $.20 and $1.06. These have been what I like to call Under the Table Offerings. Instead of the shares being distributed by underwriters to the open market, they were purchased directly by the investment firms themselves. This is a great way for those larger investment firms to get in before any move, without having to buy on the open market. They get a great price in a company they know has big potential. For those that invested in AVXL and PTBI you will remember the purchases by Aspire Capital (PTBI) multiple times before the recent run as well as the shares and 66 million warrants issued by AVXL in a similar manner. Eastern Capital Management, run by Billionaire Kenneth Dart has purchased shares from TPIV in March of this year. Does this sound familiar? If you are not familiar with Kenneth Dart, I suggest you read here: http://caps.fool.com/Blogs/who-is-kenneth-b-dart-and-why/388891 or here http://en.wikipedia.org/wiki/Kenneth_Dart If Kenneth Dart is able to exercise all of his warrants, he will own OVER 50% of TPIV. This guy is almost as big as Soros and we know what that did for PTBI.


Upcoming Catalysts:

Their abstract for their Final Phase I Breast Cancer Data has been accepted for ASCO.

The abstract tittle is:

A Phase I Trial of the Safety and Immunogenicity of a Multi-epitope Folate Receptor Alpha Peptide Vaccine Used in Combination with Cyclophosphamide in Subjects Previously Treated for Breast or Ovarian Cancer.

This has been confirmed with representatives from the company. An actual abstract number will be available on May 13th, when it is formally released by ASCO. I do not know the nature of the presentation (poster, publication, etc.), but data is expected be released, as it is a presentation of their final data from their Breast Cancer study

A combination immunotherapy, if this isn’t the hottest thing in biotech right now, I don’t know what is.

They also intend to file for Orphan Designation and Fast Track Status in Q2. This was confirmed with their CEO.

According to the FDA, the response timeline for ODD is 90 days or less, making this a Q3 catalyst.

According to the FDA, their response timeline for Fast Track Designation is 60 days or less, making this a Q2/Q3 catalyst.

Initiation of 2, Phase II Clinical Trial for Triple Negative Breast Cancer/ Ovarian Cancer and Breast Cancer is scheduled Q3, 2015. All of their trials are investigator sponsored trials through the Mayo Clinic. They intend to progress their drug development through the Mayo clinic, which results in a substantial cost savings while being associated with a prestigious medical facility. The Triple Negative Breast Cancer trial is already designed, with the Mayo Clinic (Jacksonville, FL) as the lead site, and Dr. Edith Perez as the lead investigator.

I suggest reading a little about Dr. Perez.

http://www.mayo.edu/research/faculty/perez-edith-a-m-d/bio-00027251

In sum, they will be presenting final P1 Breast cancer data in 3 weeks, waiting for ODD and FTD in the next few months, and will be initiating 2, P2 clinical trials sponsored by the Mayo clinic. With this much going and a MC of only $7 million, this is grossly undervalued. Add in the financing of Ken Dart a renown biotech guru and you have the perfect storm.

Company Overview:

From there 10K

http://www.sec.gov/Archives/edgar/data/1094038/000142488415000039/form10-k.htm

“TapImmune is a biotechnology Company focusing on immunotherapy specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer and infectious disease. The Company combines a set of proprietary technologies to improve the ability of the cellular immune system to destroy diseased cells. These are peptide antigen technologies and DNA expression technologies, Polystart™ and TAP.

To enhance shareholder value and taking into account development timelines, the Company plans to focus on advancing its clinical programs including our HER2/neu peptide antigen program and our Folate Alpha breast and ovarian trials into Phase II. In parallel, we plan to complete the preclinical development of our Polystart™ technology and to continue to develop the TAP-based franchise as an integral component of our prime-and-boost vaccine methodology.

Unlike other vaccine technologies that narrowly address the initiation of an immune response, TapImmune's ("Prime" and "Boost") approach broadly stimulates the cellular immune system by enhancing the function of killer T-cells and helper T-cells. Our peptide immunotherapeutic approach may be coupled with our recently developed in-house Polystart™ nucleic acid-based technology designed to enhance T-cell antigen presentation on the surface of appropriate populations of presenting cells. Our Polystart™ technology directs the translation and subsequent endogenous natural processing of antigenic T-cell epitopes contained within a poly-antigen array(s) at four times the level of conventional comparator systems, thereby providing a greater signal/propensity to attract and directly interact with a patient’s T-cells. Accordingly, elevated levels of target specific cell surface presented T-cell antigen(s) are correspondingly expected to more effectively engage, activate and expand antigen specific killer T-cell population(s) that can then seek out and destroy target cells (e.g., cancer cells). Moreover, our versatile Polystart™ technology is designed to express either Class I killer or Class II helper T-cell antigenic epitopes. Our nucleic acid-based systems can also incorporate “TAP” which stands for Transporter associated with Antigen Presentation.

We are currently focusing on the clinical development and testing of our product candidates. In this regard, we have two Phase I studies being concluded at the Mayo Clinic (Rochester, MN) which are designed to evaluate the safety and immune response(s) of a set of proprietary HER2/neu antigens for a HER2/neu breast cancer vaccine and Folate Receptor Alpha for triple negative breast and ovarian cancer respectively. TapImmune has the exclusive option to license each of these technologies upon the completion of each Phase I. In addition, we plan to initiate Phase II studies in 2015. The first of which will likely include the novel folate alpha antigens in a Phase II study, providing a vaccine for triple negative breast cancer that can stimulate a T-cell response. The unmet demand for a promising therapeutic in this indication, we believe, will allow us to proceed with an orphan drug and FDA fast track applications pending discussion and approval from the FDA. The second Phase II trial is expected to include our HER2/neu epitopes and will likely focus on Her2 positive breast cancer. Interim data from both phase I trials has provided the technical rational for progressing these programs to phase II trials.”

Also, the company did a reverse split in 2014, which is why the share count is so low. But as you have seen with PTBI, a reverse split with huge institutional investors clamoring up shares can lead to a very explosive opportunity.

VALUATION: (breast cancer only)

Significantly Broader Market than Herceptin a $6B/yr drug rNPV for North America & ONLY accounting for the Her2neu Breast Cancer Market: $250MM

Comparable Companies: Highly undervalued compared to other in vivo T-cell immunotherapy companies, e.g.Galena (GALE: $225MM); Immunocellular (IMUC: $154MM); Oncothyreon (ONTY: $176MM)

Management:

Glynn Wilson, Ph.D., Chief Executive Officer and Chairman

Dr. Wilson brings an extensive background of success in corporate management and product development with tenures in both major multinational pharmaceutical companies and start-up pharmaceutical/biotech organizations. Dr. Wilson's former positions include Head of Drug Delivery at SmithKline Beecham Pharmaceuticals, Research Area Head in Advanced Drug Delivery at Ciba-Geigy Pharmaceuticals, and President and co-founder of Auriga Pharmaceuticals. As Executive Vice President of R&D at Tacora Corporation he was responsible for merging the Company with Access Pharmaceuticals. He is a recognized leader in the development of drug delivery systems and has been involved in taking lead products & technologies from concept to commercialization. Glynn has a Ph.D. in Biochemistry and conducted medical research at The Rockefeller University, New York. He has been on the Board of TapImmune for 5 years.

Mark Reddish, Director

Mark was formerly Vice President of Product Development and Principal Investigator, Biodefense at ID Biomedical, Bothell, WA, prior to the acquisition of the company by Glaxo SmithKline for $1.6 billion. At Biomira Inc, (renamed Oncothyreon) he was responsible for preclinical development of their cancer vaccines program where he led the early research and clinical development of Stimuvax, which is currently in late Stage 3 clinical trials under a partnership with Merck KGa. Mark brings thirty years of biomedical experience ranging from clinical and academic research to industrial product development and has already brought significant value and insight to TapImmune as a member of the scientific advisory board. He has over 50 publications and a number of issued and pending patents in the area of vaccine technologies.

Sherry Grisewood, Director

Sherry Grisewood, CFA, has over 25 years securities industry experience in a range of investment banking, advisory and research-related activities. She is currently associated with Dawson James Securities Inc in a senior banking analytical role. Prior to joining Dawson James, she most recently inaugurated a Lifesciences specialty practice as Managing Director, Lifesciences and Technology Banking for Tripoint Global Equities. Prior to Tripoint, Ms. Grisewood served as Senior Life Sciences Banker at Jesup & Lamont Securities Corp. and as an independent strategic advisor and consultant for several investment banks over the prior 12 year period. She has participated in over 50 transaction-related projects involving initial public offerings, secondary offerings, PIPE’s, private equity, M&A and licensing transactions. These deals and projects represented US, Canadian, Scandinavian, UK, Chinese and Australian clients with advanced technologies and the development of nucleic acid therapeutics and delivery systems in the life sciences such as those addressing nucleic acid therapeutics, regenerative medicine, CNS diseases, or leading edge technologies for lifescience special situations. Prior to consulting for investment banks, Ms. Grisewood served as Director of Research for several mid-tier brokerage companies and a leading independent investment research company.

David Laskow-Pooley

Mr. Laskow-Pooley is currently CEO of LondonPharma Ltd, a clinical stage company re-purposing approved drugs through novel drug delivery technologies and is the Co-founder of Pharmafor Ltd. He was formerly Managing Director (UK) of Nasdaq- listed drug discovery platform company, OSI, and was part of the corporate team that developed and launched Tarceva for the treatment of lung cancer with marketing partners Roche and Genentech. He has had a distinguished career in multinational pharmaceutical companies including Glaxo SmithKline and Abbott, in addition to InVitrogen (Biotech Life Sciences) and Amersham, now GE Healthcare (Diagnostic Imaging). He currently serves as a non-executive director and Chairman of OBN Ltd, an industry representative for small to medium enterprises (SME's) in the UK.


Additional Info on Warrants:

On another note, I want to highlight here the warrant structure. The way the company set them up, certain warrants have to be exercised or the other ones expire worthless. The warrants listed above include A, B, C, D, and E warrants.

Each Series A warrant will have an initial exercise price of $1.50 per share, will be immediately exercisable and will expire on the five year anniversary of the date of issuance.

Each Series B warrant will have an initial exercise price of $0.40 per share, will be immediately exercisable, may be redeemed by us in the event that the closing price of our stock is above $0.70 and will expire on the six month anniversary of the date of issuance.

Each Series C warrant will have an initial exercise price of $1.00 per share, will be immediately exercisable, may be redeemed by us in the event that the closing price of our stock is above $1.50 and will expire on the five year anniversary of the date of issuance.

Each Series D warrant will be exercisable only if and to the extent that the Series B warrants are exercised, will have an initial exercise price of $0.75 per share, and will expire on the five year anniversary of the date that the Series B warrant is initially exercised.

Each Series E warrant will be exercisable only if and to the extent that the Series C warrants are exercised, will have an initial exercise price of $1.25 per share, and will expire on the five year anniversary of the date that the Series C warrant is initially exercised.

Basically, the B and C warrants have to be exercised in or the D and E warrants become worthless. Additionally, the B warrants have to be exercised within 6 months of issue, at $.40, or they expire worthless, as well as the D warrants. The B warrants will expire in June and September 2015. Thus these large firms are confident that the company will double in share price within that time. If these warrants aren’t exercised, they make no money on their investment. Big $$ rarely loses $$. Remember Kenneth Dart? I don’t think he will let these warrants expire worthless.

Summary: I believe TPIV could be an excellent play, as it possesses the best factors of both AVXL and PTBI, both of which have provided over 100% returns in the last few months. With a MC of $7million it’s ridiculously undervalued. It is an immunotherapy company, which is the hottest biotech sector and is addressing high profile indications like breast cancer and ovarian cancer. They have partnered with the Mayo Clinic to run all of their clinical trials, which keeps cost very low. A sound management team with years of experience in biotech. The have completed multiple, recent financings with institutional investors, including Kenneth Dart’s Eastern Capital Limited. Institutional ownership is over 50% and the float is somewhere between 5 and 14 million shares. They will be presenting final P1 data in 3 weeks and have a bevy of other catalysts lined up for the rest of the year (ODD, FTD, and 2 P2 clinical trials starting). There are a number of warrants that need to be exercised at prices significantly higher than the current share price. This has all the makings of a great runner. With an AVXL share price and PTBI ownership/float. This is a time bomb ready to go.