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.
Jacksonville, Florida, October 12, 2017 / TapImmune Inc. (NASDAQ: TPIV), a leading clinical-stage immuno-oncology company with ongoing clinical trials in ovarian and breast cancer, today announced that representatives of the Company will be featured in two panel discussions at the 2017 BioFlorida Conference, held October 15-17, at The Vinoy Renaissance St. Petersburg Resort and Golf Club. The Company will be featured in the BioBusiness Session on Monday, October 16th, and in the BioTrends Session on Tuesday, October 17th, and will participate in one-on-one meetings with potential strategic collaboration partners.
About BioFlorida
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JACKSONVILLE, Florida, September 25, 2017 / TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers, today announced that the Company has appointed Peter L. Hoang as its President and Chief Executive Officer. Dr. Glynn Wilson, who was recently re-appointed as Chairman by the Board, will now serve in a new role as the Company’s Strategic Advisor.
“We are delighted to welcome Peter as our new CEO, as we focus on taking TapImmune into new frontiers as a leading biopharmaceutical organization,” said Dr. Glynn Wilson, Chairman of the Board of Directors. “Peter joins us with an extraordinary background that combines capital markets, oncology, and executive management experience. We are confident that his ability and vision will lead us through the next phases of our clinical and corporate development and will enhance the value of the Company. Peter is an experienced leader and executive with proven skills in finance, operational execution, and business development, and he has the unanimous support of the Board to lead TapImmune through its clinical trials and product development.”
Mr. Hoang brings over twenty years of investment banking, venture capital, immuno-oncology and public company executive management experience to TapImmune, serving most recently as Senior Vice President of Business Development and Strategy at Bellicum Pharmaceuticals. Previously, as the Managing Director of Innovations at The University of Texas MD Anderson Cancer Center, he headed the new venture formation and development effort for the institution. Before joining MD Anderson, Mr. Hoang was a senior investment banker, most recently as Managing Director and head of healthcare mergers & acquisitions advisory for CIT Group. He has also served in the M&A departments at Oppenheimer, J.P. Morgan, Merrill Lynch, and Deutsche Bank. He earned an M.B.A. with high honors distinction from the Anderson School of Management at UCLA and a B.A. from Yale University.
Mr. Hoang has also been appointed as a member of TapImmune’s Board of Directors, and in connection with this appointment, the Board of Directors has expanded from six to seven members.
“I am very honored and excited to join TapImmune at this pivotal time,” said Mr. Hoang. “Current immunotherapies have shown great promise in treating cancer, but it has become increasingly evident that these approaches need to elicit broader immune responses in order to deliver more consistent and durable therapeutic outcomes. TapImmune’s proprietary, off-the-shelf T cell vaccine platform, with its unique MHC Class II focus, has the potential to drive robust patient immune responses and generate T cell memory that is required for lasting therapeutic effects. In addition, the company’s innovative PolyStart™ and TAP programs have the potential to enable transformative outcomes for many cancer immunotherapy approaches that currently struggle to deliver reliable and long-term patient benefits. I look forward to working with Dr. Wilson and the team at TapImmune, as well as our academic and industry partners, to advance the science, bring hope to patients, transform therapeutic outcomes in cancer immunotherapy, and create value for shareholders.”
As part of the TapImmune succession planning process, the Board undertook a comprehensive, global search for a top tier executive with experience across multiple functional areas of the biopharmaceutical industry. The worldwide search was conducted by Gayle Mattson, principal of Mattson and Company, New York, a boutique firm specializing in CEO and Board Searches.
Recent Corporate and Clinical Developments:
- Achieved 50% enrollment in ongoing Phase 2 dosing study of TPIV 200 for treating triple-negative breast cancer (TNBC)
- Completed $6.8 million financing; combination of private placement and exercise of Series E warrants
- Amended Phase 2 platinum-sensitive ovarian cancer study protocol to allow women in their first remission to receive TPIV 200 vaccination
Anticipated 2017 Milestones:
- Publish long-term safety, immune response and survival data from completed Phase 1 clinical study of TPIV 200
- Report interim results from ongoing Phase 2 study of TPIV 200 in combination with AstraZeneca’s durvalumab in patients with platinum-resistant ovarian cancer
- Complete enrollment in TapImmune Sponsored Phase 2 study of TPIV 200 in TNBC
File amended investigational new drug application (IND) for TPIV 110 for treating HER2/neu+ breast cancer
JACKSONVILLE, FLORIDA – August 31, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers, today provided its business update for the second quarter 2017. A public conference call and live audio webcast is scheduled for today at 4:30 p.m. ET.
“During the second quarter, we continued to focus on advancing our robust clinical development pipeline, which consists of several internal programs and clinical collaborations with top-tier partners,” said Dr. Glynn Wilson, Chairman and CEO of TapImmune. “In order to reach meaningful value inflection points for our shareholders, our primary objective for the next several quarters is to continue enrolling patients into our three active Phase 2 trials as efficiently as possible. In parallel, we anticipate launching additional clinical studies for each of our novel cancer vaccine candidates later this year. We expect to deliver on multiple substantive clinical milestones across our entire pipeline over the next 18 months, and we are optimistic that this continued clinical execution should lead to several catalysts for the company and its shareholders over the coming quarters.”
Dr. Wilson continued, “We are also exploring multiple opportunities to leverage our vaccine-enhancing PolyStart™ technology. This platform represents a strategic approach to continue fueling our internal vaccine pipeline in oncology, as well as a potentially valuable opportunity to out-license this asset to strategic partners developing vaccines for infectious disease. We expect to initiate those discussions as our technology continues to mature.”
Current Clinical Studies:
TPIV 200: Lead T-cell vaccine targeting folate receptor alpha
- Memorial Sloan Kettering-sponsored Phase 2 combination study with AstraZeneca’s durvalumab in platinum-resistant ovarian cancer
Results from the planned interim analysis are expected to be available later in 2017. If the safety profile remains favorable and there are sufficient signs of tumor response, patient enrollment will resume and TapImmune expects the study to be completed as planned in 2018. - FDA Fast Tracked Phase 2 maintenance therapy study in platinum-sensitive ovarian cancer
A recent protocol amendment enables TapImmune to enroll women earlier in the treatment cycle (during first remission). These women are more likely to have healthier immune systems and may be better positioned to benefit from TPIV 200 immunotherapy. TapImmune plans to conduct an interim analysis once data is available from the first half of patients enrolled (under the amended protocol), which is currently expected in early 2019. This program will benefit from FDA Fast Track as well as Orphan Drug designation. - Multi-center Phase 2 dosing study in triple-negative breast cancer
The randomized study is designed to determine the optimal vaccine dose and regimen that may maximize the anti-tumor immune response in maintenance-phase patients, who have completed standard surgery and chemotherapy/radiation. Study enrollment has surpassed 50% and enrollment completion is anticipated by year end 2017. Once enrolled, top-line data from the completed study is anticipated in the second half of 2018.
Planned Clinical Studies:
TPIV 100/110 T-cell vaccine targeting HER2/neu:
- TapImmune plans to initiate a Phase 1b/2a clinical trial of TPIV 110 for treating women with HER2/neu+ breast cancer once an amended investigational new drug application (IND) is completed by year-end 2017 and upon FDA acceptance of the amended IND.
Conference Call and Webcast Information:
The company will host a conference call and live audio webcast today, August 31, 2017, at 4:30 p.m. ET. Interested participants and investors may access the conference call by dialing either:
- (855) 238-2333 (U.S.)
- (412) 317-5215 (International)
An audio webcast will be accessible via the New and Events section of the TapImmune website https://markertherapeutics.com/events/. An archive of the webcast and presentation will remain available for 90 days beginning at approximately 6:30 p.m. ET, on August 31, 2017.
JACKSONVILLE, FLORIDA – August 29, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers, today announced that the Company will host a conference call and live audio webcast on Thursday, August 31, 2017, at 4:30 p.m. ET, to provide a corporate and clinical update for the Second quarter 2017.
Reserve Your Seat: Register Today
The event will be webcast live via the Internet on:
August 31, 2017
4:30 PM ET
Click Here to register today, or visit https://www.webcaster4.com/Webcast/Page/1651/22470.
Day-of Call-in Information:
To access the live conference call, dial:
- (855) 238-2333 (U.S.)
- (412) 317-5215 (International)
To access the live audio webcast, visit the Events section of the TapImmune website https://markertherapeutics.com/events/. The webcast will also be archived for 90 days beginning at approximately 6:30 p.m. ET, on August 31, 2017.
Jacksonville FL, August 7, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers, today announced that, in coordination with the U.S. Food and Drug Administration (FDA), it has amended the patient inclusion criteria for its Phase 2 clinical trial of the Company’s T-cell therapeutic peptide vaccine TPIV200 to focus on women with Stage III and IV ovarian cancer who are in remission following their first round of successful platinum-based chemotherapy. TapImmune has enrolled the first women under this amended study protocol, which significantly expands the population of patients that can be addressed with TPIV 200 as a potential maintenance therapy designed to prevent disease recurrence.
TPIV200 targets the folate receptor alpha protein, which is overexpressed by most patients with ovarian cancer, and the vaccine has generated durable immune responses in a completed Phase 1 study. TapImmune sought to amend the clinical protocol following extensive discussion with its clinical advisors regarding the unmet need in this patient population and in anticipation of FDA approval of niraparib for women with recurrent disease. Patients in their first remission following platinum therapy currently have no approved therapeutic option to prevent disease recurrence, which occurs at a high rate. Therefore, these patients are in the best position to benefit from TPIV 200 maintenance therapy.
“Our investigators, as well as their ovarian cancer patients, are enthusiastic about this trial, which is intended to demonstrate enhanced progression-free survival for women prior to their first recurrence.” said Dr. Richard Kenney, Head of Clinical Development at TapImmune. “Shifting our focus to earlier in the treatment cycle enables TapImmune to showcase the potential of our novel T cell vaccine in a much larger patient population. Furthermore, should TPIV 200 demonstrate a significant benefit for these women in prolonging the time to disease recurrence, the Company will be well positioned within the current treatment paradigm for ovarian cancer, which now includes the PARP inhibitor niraparib for treating patients with recurrent disease.”
The Phase 2 ovarian cancer trial is a double-blind controlled study designed to examine the potential benefits of using the Company’s lead product candidate TPIV200 following standard of care platinum-based chemotherapy. Study size was increased to 120 patients to better evaluate the effect of the immunotherapy and to achieve statistical significance of efficacy data. TPIV200 has Fast Track designation from the FDA and Orphan Drug status for ovarian cancer.
JACKSONVILLE, FLORIDA – July 18, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers, announced today that Dr. Glynn Wilson, Chairman and CEO of TapImmune, will chair a panel discussion on the future of combination therapies in oncology at a meeting of the Northeast Chapter of BioFlorida on Wednesday, July 19, 2017. The meeting is to be held at the University of Florida’s Health Proton Therapy Institute in Jacksonville, Florida.
Details of the panel discussion are as follows:
Event: BioFlorida Northeast Chapter Meeting, Jacksonville
Date: Wednesday, July 19, 2017
Time: 5:30 p.m. (Eastern Time)
Location: University of Florida Health Proton Therapy Institute
JACKSONVILLE, FLORIDA – June 27, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers, announced that it has enrolled 50% (40/80) of the patients in its randomized Phase 2 clinical study of its novel T-cell vaccine candidate TPIV 200 for treating triple-negative breast cancer (TNBC). The four-arm study is designed to determine the optimal vaccine dose and regimen to maximize the immune response generated against the vaccine’s molecular target, folate receptor-alpha (FRa).
The multi-center Phase 2 study continues to enroll women with stage I(T1c)-III TNBC who have completed initial surgery and radiation/chemotherapy, and who have not yet had a cancer recurrence. It is during this window of opportunity that TPIV 200 is used to vaccinate patients in an effort to delay or prevent cancer recurrence by stimulating the immune system to produce T-cell immunity specific for tumor antigens.
Dr. Richard Kenney, Head of Clinical Development for TapImmune, stated, “We are very pleased with the rate of patient enrollment in this Phase 2 study, which has allowed us to reach this key milestone ahead of our projections. We believe this speaks to the enthusiasm and dedication of our clinical investigators, trial site collaborators, and clinical operations team. We look forward with confidence to completing patient enrollment by the end of the year.”
TNBC occurs in 10-15% of all women with invasive breast cancer and is associated with poor prognosis. Women with TNBC derive no benefit from targeted therapies. Excluding the minor fraction of women who respond to neoadjuvant chemotherapy (~15%), seven-year survival is only 45%.
Dr. Glynn Wilson, Chairman and CEO of TapImmune, stated, “Delivering shareholder value through continued clinical execution remains our top priority. We remain on track to reach multiple value inflection points throughout the second half of 2017 and 2018, driven by significant advancements in our ongoing and planned clinical trials. We thank the patients for their participation and look forward to completing patient enrollment by the end of the year. In addition, we are continuing to validate our PolyStart™ antigen expression technology in preclinical studies, which we anticipate may drive partnership interest from vaccine developers in the areas of oncology and infectious disease.”
JACKSONVILLE, Florida, June 22, 2017 / TapImmune Inc. (Nasdaq Capital Market: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers, announced today that it has entered into definitive subscription agreements to raise aggregate gross proceeds of approximately $6.82 million in a private placement transaction with accredited investors and from the exercise of certain outstanding Series E warrants by certain existing institutional investors. The closings of the transactions are subject to delivery of funds from the investors and are expected to occur on June 26, 2017.
Glynn Wilson, Chairman and CEO of TapImmune, stated: “We are pleased with the continued interest and investment in TapImmune which will fund us through several significant clinical milestones in the advancement of our novel T-cell vaccines for breast and ovarian cancer. In addition, we believe that the warrant exercise illustrates the support our current investors have for our continued progress and successful clinical execution. We believe that these events can provide a catalyst for our future growth in one of the most rapidly growing sectors of the oncology market.”
TapImmune expects to use the net proceeds for general corporate purposes, including clinical trial expenses and research and development expenses over the next 18 months. The Company expects to achieve a number of clinical milestones this year, including publication of the Phase I trial results for TPIV 200 to include safety, survival and overall immune responses. Currently TPIV 200, a T-cell cancer vaccine targeting folate receptor alpha, is being evaluated in three Phase 2 trials with a fourth planned to start in the fourth quarter of this year. One study is being run at the Mayo clinic and funded by a grant from the U.S. Department of Defense targeting triple-negative breast cancer. A second study is ongoing in platinum-resistant ovarian cancer at Memorial Sloan Kettering Cancer Center in New York City in collaboration with AstraZeneca. TapImmune is also sponsoring the final two studies in platinum-sensitive ovarian and triple-negative breast cancer. TapImmune plans to fund these studies as well as begin clinical development of its Her2/neu vaccine candidate TPIV 110.
In the private placement transaction, TapImmune has agreed to sell 1,503,491 shares of common stock for $3.97 per share (the consolidated closing bid price for the common stock on June 21, 2017) and five-year warrants to purchase an equal number of shares of common stock, at an exercise price of $3.97 per share, for $0.125 per warrant, with the shares and warrants being sold as a unit for a total of $4.095 per unit. In addition, the Company reduced the exercise price for the warrants to purchase an aggregate of 653,187 shares of common stock issued to investors in the private placement that closed in August 2016 from $6.00 per share to $3.97 per share. Investors in the current private placement transaction also paid the Company $0.125 for each share subject to such investor’s 2016 warrant.
Katalyst Securities served as the placement agent for the private placement transaction.
TapImmune and certain existing institutional investors, who are holders of various warrants to purchase shares of Company common stock, entered into Warrant Exercise Agreements in which the Company agreed to reduce the exercise price for a portion of the investors’ existing Series E warrants from $15.00 per share to $3.97 per share, provided that the investors exercise such portion of the warrants immediately, for aggregate proceeds of approximately $666,666, with the exercise price for 75% of the remainder of the investors’ Series E warrants being reduced from $15.00 per share to $4.50 per share. The remainder of such investors’ Series E warrants would retain their current exercise price. Additionally, the exercise price for 75% of such investors’ other warrants (other than Series A warrants) warrants will be reduced to $4.00 per share.
The securities to be sold in this private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws, and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission (the “SEC”) registering the resale of the shares of common stock issued in the private placement, and the shares of common stock issuable under the warrants issued in the private placement, including the warrants issued to Katalyst Securities.
TapImmune is filing today a Current Report on Form 8-K with the SEC that provides additional details regarding these matters, pending closing, and readers are encouraged to read such Form 8-K and the exhibits thereto in their entirety.
This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.
JACKSONVILLE, FLORIDA – June 14, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers, today announced that Dr. Glynn Wilson, Chairman and CEO of TapImmune, will present at the 2017 Biotechnology Innovation Organization International Convention held on June 19-22 in San Diego.
Date: Tuesday, June 20, 2017
Time: 3:30 PM (Pacific Time)
Location: Theater 2, San Diego Convention Center, San Diego, CA