FREQUENTLY ASKED QUESTIONS

INVESTOR FAQS

What does TapImmune do? What is your mission?

We are a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers. Our mission is to broadly activate T-cells to recognize and kill specific cancer targets in addition to improving antigen presentation.

What is the core idea and innovation of TapImmune?

The core idea is to use antigens either as peptides or through nucleic acid expression and to get them naturally processed by antigen presenting cells to present the target to the T-cells and broadly stimulate them. That means stimulating both the CD4 cells and the CD8 cells. We have both technologies, both peptides, and we have a new nucleic acid technology called PolyStart which we are very excited about.

How is TapImmune different from other companies?

Our focus on women’s cancer is a key differentiator because women’s cancer, whether it’s ovarian or triple negative breast, is not a natural target for immunotherapy like checkpoint inhibitors. They’re good targets for vaccines because most of the patients that we examine have a high rate of recurrence after front line treatments. From inception, we focused broadly on stimulating the T-cell system. Our initial work in this field focused exclusively on CD8 cells and killer cells. We now know that we can’t get a viable and long lasting CD8 response without having a CD5 response stimulating helper cells, so we’ve done both of these.

Who is TapImmune in collaboration with?

We collaborate with the Mayo Clinic, Memorial Sloan Kettering, and AstraZeneca. We started looking for technologies in the same space that had a good clinical pathway, and we were able to link up and start a very significant relationship with the Mayo Clinic. Our phase 1 studies for two vaccines were done at the Mayo Clinic in Rochester, and now we are working closely with the May Clinic in Jacksonville. In addition, our collaborators at the Mayo Clinic have been able to persuade the U.S. Department of Defense to put in almost $18 million to fully fund two phase 2 programs The first of their funding came in the form of a grant to the Mayo Clinic for $13.3 million and was one of the larger grants they’ve given out for breast cancer. The most recent funding was from DCIS to the Mayo Clinic for almost $4 million.

Our collaboration with Memorial Sloan Kettering in New York is also in conjunction with the pharmaceutical collaborator, AstraZeneca, for the checkpoint inhibitor. Our phase 1 studies in the background to vaccine development went through the global clinical team at AstraZeneca in the UK. They came back and wanted to do the study with us at Memorial Sloan Kettering.

These significant collaborations have turned over the proverbial rocks in our programs and looked deeply into the background of what we are developing.

How was TapImmune able to obtain the fast track designation from the FDA?

The FDA gives a fast track designation for a specific clinical indication where there is a huge clinical need. In our case, it was for ovarian cancer patients that are actually responding to platinum, but it is inevitable that these patients will become resistant at some stage. We are adding the vaccine after the last dose of platinum therapy, where they have been responsive, and looking at how we can maintain that therapy by adding a vaccine in. It’s a nice clinical trial because the regular pathway to standard of care is a good one.

What is PolyStart?

One of the issues with DNA vaccines is the potency, so PolyStart uses alternative codons for initiation. In addition of having AUG, you have at least three CUGs. There is one DNA that makes one RNA that makes one protein, normally, but in the case of PolyStart there can be one DNA, one RNA, and at least four (but probably a lot more) proteins produced. There is a much better signal. We can combine that initiation cassette with what we call a poly-antigen array cassette that can mix and match antigens. It can be used not only for cancer but also for other viral diseases.

How can someone enroll in a clinical trial?

We are currently conducting clinical trials for triple negative breast cancer, platinum sensitive ovarian cancer, and platinum resistant ovarian cancer. More information about our clinical trials is available at www.clinicaltrials.gov. Normal treatment for these types of diseases can be chemotherapy, radiation therapy, or surgery. We are developing vaccine immunotherapies designed to create a lasting “memory” T-cell response that may be effective against both the primary tumor and metastases.

If you are currently under care for your condition, please ask your physician to contact us on your behalf. If you would like to stay updated on our research and progress, please sign up for our newsletter.

In the Clinical Trials, how is the vaccine administered?

It is administered by a simple subdermal injection. The injection compares to a flu shot that everyone receives.

Do you anticipate either of the two lead products, TPIV200 or TPIV110, will need a booster? If so, at what interval(s)?

We think it is likely, and we are currently testing this in a company sponsored trial on triple negative breast cancer. The boost in these studies will be given 6 months after the end of a course of injections.

Where can I find recent press releases?

You can view our recent press releases by going to our Press Release section of the website.

Where can I review TapImmune’s financial filings?

Quarterly & Annual Reports and other investor materials, when available, can be found in Financials & Filings in the Investor Relations section of our corporate website.

Can I receive TapImmune Updates?

Yes you can. Sign up to be on the TPIV VIP list.