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Tuesday, 11/07/2017 12:46:01 AM

Tuesday, November 07, 2017 12:46:01 AM

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We received 2 copies of this letter in our mail Monday from the new CEO of TPIV. I did not find it in the IBOX above, which reflects different management still extant. Perhaps the letter was posted earlier, and I missed it.


https://tapimmune.com/2017/10/a-personal-letter-to-the-shareholders-from-tapimmunes-new-chief-executive-officer/

"Jacksonville, Florida, October 18, 2017 / TapImmune Inc. (NASDAQ: TPIV), a leading clinical-stage immuno-oncology company with ongoing clinical trials in ovarian and breast cancer, announces a letter from the CEO.

My fellow shareholders,

I feel humbled by the opportunity to speak to you for the first time as CEO of TapImmune. I know that many of you have supported us for many years, and I thank you for the faith that you have placed in us. For many of you, I am a relatively unknown entity, and as such, I wanted to introduce myself and share with you what excites me about our company.

I hope that by describing my perspective on our industry and my vision for TapImmune within it, I might inspire your confidence that our company is guided by experienced and steady hands. I also want to convey my fiery conviction that our company can fundamentally change our industry, as well as my unwavering resolve to drive TapImmune to its full potential.

It is hard to overstate how profoundly immunotherapies have transformed the treatment of cancer. Patients who, merely ten years ago, might have been admitted to a hospital and given a prognosis of only days to live, are today walking out of those hospitals only a few weeks later virtually disease-free. We hesitate, as an industry, to utter the word “cure”, but we now see in some patients complete remissions that seem to be indefinitely durable.

It is easy for us to forget that there was a time before immunotherapies routinely delivered such transformative outcomes. That time was not so long ago. Merely fifteen years ago, most of the financial world considered the idea of enlisting the immune system to fight cancer to be a fool’s errand. Even ten years ago, many of the ideas that today seem natural might have been laughed out of the room.

On a personal note, I married a cancer researcher. She was a member of the scientific team whose work led to the approval of the first checkpoint therapy, and I can remember when ipilimumab was first approved by the FDA in the spring of 2011. The date still echoes in my memory because it was a celebratory milestone, the culmination of many years of work for her and her colleagues. More importantly, it is a reminder that almost everything we know about successful checkpoint immunotherapies has been learned from treating patients over the last ten years.



My own experience in helping to advance CAR-T and TCR therapies at MD Anderson and Bellicum also reminds me that everything we know about successful cell-based immonutherapies has been gleaned from what we’ve observed in only the last five years.

This history is important, because it underlines the fact that the cancer immunotherapy field is incredibly young and fast-moving, and we still have much to learn about why some patients respond to immunotherapies while others do not. However, we know much more today than we did even two or three years ago.

What we have learned gives me great hope and conviction that TapImmune and its therapies can play an important role, and perhaps an essential one, within the immuno-oncology ecosystem.

We have learned that in many cases, simply “removing the brakes” from the immune system isn’t enough. Checkpoint inhibitors deliver their best outcomes when mutations are frequent in a tumor. However, when the rates of mutation are lower, the immune system still struggles to recognize and overcome tumors even when cancer-related inhibitory signaling is blocked.

We have also learned that in solid tumors, CAR-T and TCR therapies struggle to deliver consistent and durable responses, when they deliver any response at all. Unlike in blood cancers, exquisitely targeted T-cells appear to require assistance from a broad-based immune response to be effective in solid tumors.

This recent clinical experience tells us that cancer immunotherapies must do better at enabling patients’ immune systems to perform more efficiently, even when the “brakes” are removed. We must better enable the endogenous immune system to detect and destroy cancer cells, which continue to evade detection and elimination even when immunosuppression is reduced. We must help generate memory in a wide range of T-cell specificities and help trigger a broad-based immune response that can out perform an aggressive tumor. Moreover, we must find a way to develop a therapy that is effective across the entire population, with processes that can ensure that our therapies remain affordable and broadly applicable.

All of these things are exactly what TapImmune’s therapeutic approaches do.

TapImmune’s off-the-shelf T-cell vaccines elicit a broad-based T-cell response and can be used with the vast majority of the population. They generate powerful immune responses in more than 90% of the patients who receive our treatments in early clinical trials. Unlike vaccine approaches that have failed, our approach builds upon a growing scientific consensus that targeting helper T-cells is essential to generating immune memory and enabling killer T-cells to perform well. To further enhance all of those elements, our PolyStart™ platform helps drive antigen presentation and make tumors more visible to the immune system.

This conviction, that our technologies can save lives and transform cancer treatment, brought me to TapImmune. I believe that our people and our energy can drive our therapies through to regulatory approval and commercial success. I am convinced that our approach will motivate others to join with us and let us improve help them improve their immunotherapy approaches that have to date struggled to be consistently effective and durable. In essence, I believe that TapImmune has the opportunity to lead the industry in translating the promise of cancer immunotherapy into life-changing therapies.

However, as much as I believe in our mission and our capabilities, I also believe that my primary mandate is to find ways to make us better at what we do.

We must execute more crisply than we ever have so that we may secure our place in the increasingly competitive immuno-oncology landscape.

We must drive ourselves to become a more efficient organization in the prosecution of our clinical trials so that we achieve every milestone that we set out for ourselves.

We must better communicate our value proposition to the capital markets to ensure that TapImmune is appropriately valued in the marketplace.

Most of all, we need to be available and responsive to you, our shareholders. You are, and will continue to be, the lifeblood of our company. It is your commitment and faith that enables us to pursue our mission and develop products we believe will change the face of cancer care.

I thank all of you for supporting us in this vision.



With my warmest regards,

Peter L. Hoang

President & CEO

TapImmune Inc."
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