TapImmune CEO Provides Update on Corporate Activity and Progression of Clinical Programs
September 23, 2014
I am pleased to provide this update to existing shareholders and interested potential shareholders
TapImmune is a clinical-stage immunotherapy company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer and infectious disease. The company now has multiple clinical trials underway at the Mayo Clinic in Rochester, MN, as well as an infectious disease program also completing pre-clinical testing at Mayo for a novel smallpox vaccine. In addition to our own sponsored clinical trials, we recently announced that a new grant-funded breast and ovarian cancer trial was started by Mayo using the same Folate Alpha receptor peptides to which we have the exclusive rights. Our development pipeline is extremely strong and provides us the opportunity to continue to expand on collaborations with leading institutions and corporations.
Over the past three quarters, we have significantly strengthened our balance sheet by raising additional working capital and reducing our stockholders’ deficit from $8.7M in December 2013 to $2.5M in Q2. On August 14, 2014, we closed a $2 million registered direct offering with a fundamental institutional investor, giving us confidence in our ability to continue developing our products on the path to commercialization. The strength of our science and development approaches is becoming more widely appreciated, particularly as our clinical program has now generated positive interim data on both clinical programs in Breast and Ovarian Cancer. Also, I am pleased to report that all our pre-clinical programs are seeing positive outcomes.
With the new funding the Company is focusing on the following key initiatives:
Entry into Phase 2 Her2Neu Breast Cancer Trials
Entry into Phase 2 Ovarian Cancer Trials and Orphan Drug Status
Completion of Pre-Clinical SmallPox Program at Mayo and planning for next developmental steps in Non-Human primates.
Produce newPolyStart constructs, in-house, to facilitate collaborative efforts in our current clinical indications and those where others have already indicated interest in combination therapies.
In addition, we will continue to work on deficit reduction and capital improvement in order to make the required benchmarks for an uplisting to the NASDAQ
Together, these fundamental programs and corporate activity have positioned TapImmune extremely well to capitalize on the acceptance of immunotherapy as a leading therapeutic strategy in cancer and infectious disease resulting in exploding valuations in the market.
Tap Immune’s Pipeline
The Company has a deep pipeline of potential blockbuster immunotherapies under development. Two of the clinical programs are completing successful Phase 1 studies and are expected to advance to Phase 2 this year or early in 2015. These are major inflection and valuation events, and we believe that, in light of these assets, the company is significantly undervalued. Over the past few months a number of highly visible transactions and billion dollar acquisitions have taken place that validate the work we are doing. We believe that, if our treatment successfully reaches commercialization, our treatment is applicable to 50% of the Her2Neu Breast Cancer market — which is a $21bn annual market. We further believe that if our Ovarian Cancer treatment reaches commercialization, it will be applicable to 95% of the market which Decision Resources, one of the worlds leading research firms for pharmaceuticals and healthcare, believes will triple in the next 10 years to at least $1.5bn.
In addition to the exciting clinical developments, our peptide vaccine technology may be coupled with our recently developed in-house Polystart™ nucleic acid-based technology designed to make vaccines significantly more effective by producing FOUR times the required peptides for the immune systems to recognize and act on. Our nucleic acid-based systems can also incorporate “TAP” which stands for Transporter associated with Antigen Presentation. This platform can increase the efficacy of a smallpox vaccine by at least 100 fold.
You can’t turn on the news today without seeing the need for vaccine development, whether it’s Ebola, SARS, West Nile, Bird Flu etc. The world is now truly a global village, and an outbreak in West Africa or China is a serious threat elsewhere in the world. Our platform technologies are designed to be extremely versatile and, as such, can be used to make just about any vaccine more effective in a number of ways. Although we have been approached by interested parties, we continue to seek collaborators in these areas of development. While further testing and research is required, we believe that our platform technologies are a significant advance in vaccine technology development that could play a significant role in the fight against numerous emerging threats, such as Ebola, SARS, West Nile, Bird Flu, by creating new vaccines or greatly improving those already in development. As a major strategic option, we will continue to seek new collaborations in these areas of development.
With respect to validation of our technologies, it is important to note that the majority of our technologies have been published in leading peer-reviewed journals. The timing of such publications is consistent with the filing of patents.
A list of publications on our TAP technology can be found on our website (markertherapeutics.com). Publication of our data on PolyStart will occur after current patent filings have been completed.
A key component to success is having a comprehensive patent strategy that continually updates and extends patent coverage for key products. It is highly unlikely that early patents will extend through ultimate product marketing, so extending patent life is an important strategy for ensuring product protection. TapImmune is working with Seed IP in Seattle, one of the best IP law firms in the biotechnology arena, to effect such a strategy. In addition, we are fortunate that Dr. Robert Florkiewitz at TapImmune is a registered patent agent with an extensive background in this field.
TapImmune has five patent estates, details of which can be found on our website:
1. Issued and filed patents on TAP for treatment of cancer and infectious disease (owned by TapImmune)
2. Filed patents on PolyStart expression vector (owned by TapImmune and filed in 2014)
3. Filed patents on HER2/neu Class II and Class I antigens: exclusive license from Mayo Clinic
4. Filed patents on Folate receptor alpha antigens exclusive license option from Mayo Clinic
5. Issued patents on Vaccinia virus antigens: exclusive license option from Mayo Clinic
While the pathway to successful product development takes time and significant resources, we believe that we have put in place the technical and corporate fundamentals for success. The strength of our product pipeline and access to leading scientists and institutions gives us a unique opportunity to make a major contribution to global health care.
A number of early stage billion dollar pharma acquisitions and recent IPOs have highlighted the growing interest in investment in immunotherapy space. Looking at our current valuation and those of our peers and considering our pipeline of clinical programs with very near-term advancements and the value inflections those represent, we believe this is an excellent opportunity and presents exceptional entry point for those that have not yet become shareholders.
We thank our shareholders for their continued support and hope that all interested parties will continue to follow our progress closely as we approach some significant milestones and value drivers this year.
About TapImmune Inc.
TapImmune Inc. is an immunotherapy company specializing in the development of innovative vaccine technologies for the treatment of cancer and infectious disease. The Company’s vaccine compositions, peptide or nucleic acid-based, comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patients’ killer T-cells, helper T-cells and to restore or further augment antigen presentation by the modulation of TAP (Transporter associated with Antigen Processing). The Company believes that its vaccine compositions may be used as stand-alone medications or in combination with current treatment modalities. Please visit the Company’s website at markertherapeutics.com for details.
Forward-Looking Statement Disclaimer: This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements”. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K and other SEC filings which are available through EDGAR atwww.sec.gov. The Company assumes no obligation to update the forward-looking statements
For TapImmune Inc.
Glynn Wilson, PH.D., 866-359-7541
Chairman & CEO
J.Streicher Capital, LLC.