UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
November 30, 2015
Date of Report
TAPIMMUNE INC.
(Exact name of registrant as specified in its charter)
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Nevada
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000-27239
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88-0277072
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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50 N. Laura Street, Suite 2500
Jacksonville, FL
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98102
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(Address of principal executive offices)
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(Zip Code)
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(206) 504-7278
Registrant’s telephone number, including area code
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 3.02 Unregistered Sales of Equity Securities.
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On July 16, 2015, the U.S. Securities and Exchange Commission declared effective Post-Effective Amendment No. 2 to our Registration Statement on Form S-3 on Form S-1. The Registration Statement registered, among other securities, shares of our common stock underlying Series A Warrants and Series C Warrants. Between November 30, 2015 and December 9, 2015, holders of the Series A warrants exercised 4,832,000 of the Series A warrants and 892,000 of the Series C Warrants registered under that Registration Statement. As a result of those exercises:
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we received approximately $483,200 in cash for the exercise of the Series A Warrants and $446,000 for the exercise of the Series C Warrants (which funds we intend to use for general corporate purposes and working capital) and
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we issued 5,712,000 shares of common stock, which amounts to approximately 8.1% of all shares outstanding immediately after such issuance.
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Item 8.01 Other Events.
On December 7, 2015, we issued a press release entitled “TapImmune to Present New Data at San Antonio Breast Cancer Symposium on December 10, 2015.” A copy of that press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
On December 9, 2015, we issued a press release entitled “U.S. Food & Drug Administration Grants Orphan Drug Designation to TapImmune's TPIV 200 in the Treatment of Ovarian Cancer.” A copy of that press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
On December 10, 2015, we issued a press release entitled “TapImmune Presents New Data at San Antonio Breast Cancer Symposium Showing Robust Generation of T-Cell Immunity.” A copy of that press release is attached hereto as Exhibit 99.3 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
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Exhibit 99.1
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Press release entitled “TapImmune to Present New Data at San Antonio Breast Cancer Symposium on December 10, 2015” issued on December 7, 2015
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Exhibit 99.2
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Press release entitled “U.S. Food & Drug Administration Grants Orphan Drug Designation to TapImmune's TPIV 200 in the Treatment of Ovarian Cancer” issued on December 9, 2015
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Exhibit 99.3
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Press release entitled “TapImmune Presents New Data at San Antonio Breast Cancer Symposium Showing Robust Generation of T-Cell Immunity” issued on December 10, 2015
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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TAPIMMUNE INC.
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Date: December 11, 2015
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By: /s/ Glynn Wilson
Name: Glynn Wilson
Title: Chairman and CEO
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Exhibit 99.1
TapImmune to Present New Data at San Antonio Breast Cancer Symposium on December 10, 2015
PR Newswire
JACKSONVILLE, Florida, December 7, 2015
JACKSONVILLE, Florida, December 7, 2015 /PRNewswire/ --
TapImmune, Inc. (TPIV), a clinical-stage onco-immunology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, today announced its Chairman and CEO, Dr. Glynn Wilson, will be presenting new data at the 2015 San Antonio Breast Cancer Symposium, which will be held in San Antonio, Texas onDecember 8 - 12, 2015.
Data will be presented at the poster session, "Treatment: Immunotherapy" on Thursday, December 10, from 7:30 am to 9:00 am. The poster titled, "Robust generation of T-cell immunity to HER2 in HER2+ breast cancer patients with a degenerate subdominant HLA-DR epitope vaccine," was co-authored by Dr. Wilson, Dr. Knutson, Dr Degnim and other researchers from the Mayo Clinic in Rochester, MN.
The poster presentation will include previously unpublished data from a concluded Phase 1 trial conducted at the Mayo Clinic on a T-cell stimulating vaccine (TPIV 100) for the indication of HER2/neu breast cancer. TapImmune has the Exclusive Option to license this technology from the Mayo Clinic. The percent of patients that responded with augmented T cell immunity to the four peptide antigens contained in the vaccine was high for each peptide ranging from 68-88%, which led to the 90% of the patients augmenting T cells that recognized naturally processed HER2 antigen. "This presentation will present evidence of a robust and significant immune response using antigens designed to target HER2/neu epitopes known to be important targets in a variety of cancers. These are compelling data that has made us excited about initiating development efforts towards a Phase 2 program with this product" stated Dr. Wilson
About TapImmune Inc.
TapImmune Inc. is an immunotherapy company specializing in the development of innovative technologies for the treatment of cancer, including metastasis, and infectious disease. The Company's peptide or nucleic acid-based immunotherapeutics, 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 using proprietary nucleic acid-based expression systems. The Company's technologies may be used as stand-alone medications or in combination with current treatment modalities. Please visit the Company's website at http://www.tapimmune.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, 10-Q and other SEC filings which are available through EDGAR at http://www.sec.gov . The Company assumes no obligation to update the forward-looking statements.
Contacts:
TapImmune Inc.,
Glynn Wilson, Ph.D.
Chairman & CEO
+1-866-359-7541
Exhibit 99.2
U.S. Food & Drug Administration Grants Orphan Drug Designation to TapImmune's TPIV 200 in the Treatment of Ovarian Cancer
Company preparing for Phase II ovarian cancer trial based on positive data in Mayo Clinic Phase I trial
PR Newswire
JACKSONVILLE, Florida, December 9, 2015
JACKSONVILLE, Florida, December 9, 2015 /PRNewswire/ --
TapImmune, Inc. (TPIV), a clinical-stage immunology-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, announced today that it has received Orphan Drug Designation from the U.S. Food & Drug Administration's Office of Orphan Products Development (OOPD) for its cancer vaccine TPIV 200 in the treatment of ovarian cancer. The TPIV 200 ovarian cancer clinical program will now receive benefits including tax credits on clinical research and 7-year market exclusivity upon receiving marketing approval.
TPIV 200 is a multi-epitope peptide vaccine that targets Folate Receptor Alpha which is overexpressed in multiple cancers including over 90% of ovarian cancer cells. In Phase I clinical studies conducted at the Mayo Clinic in patients with breast and ovarian cancer this vaccine was shown to be safe and well tolerated and to give robust cellular immune responses in 20 out of 21 evaluable patients. Further, the data showed that 16 out of 16 patients in the observation stage still showed immune responses. Data from the Phase I studies were published in the Journal of Clinical Oncology covering the American Society of Clinical Oncology meeting in May 2015. Multiple Phase II studies will examine the efficacy of this vaccine in ovarian and triple negative breast cancer.
"Ovarian cancer is highly aggressive, clinically evasive, and with current treatment modalities time to recurrence is relatively short and prognosis upon recurrence is poor," commented Dr. Patrick Yeramian, MD, Vice President and Chief Medical Officer at TapImmune. "The FDA's decision to grant TPIV 200 Orphan Designation underscores the need for additional therapeutic options and validates the scientific rationale of TapImmune's approach."
Approximately 21,290 women were diagnosed with ovarian cancer in 2015 and an estimated 14,180 will die from the disease according to the American Cancer Society. Because ovarian cancer tends to be detected at a later stage of the disease, the 5-year survival rate for ovarian cancer is 45%. Current treatment options are surgery, radiation and chemotherapy. There is currently no FDA approved cancer vaccine available for ovarian cancer.
About TapImmune Inc.
TapImmune Inc. is an immune-oncology company specializing in the development of innovative technologies for the treatment of cancer, including metastasis, and infectious disease. The Company's peptide or nucleic acid-based immunotherapeutics, 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 using proprietary nucleic acid-based expression systems. The Company's technologies may be used as stand-alone medications or in combination with current treatment modalities. Please visit the Company's website at www.tapimmune.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, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update the forward-looking statements.
Contacts:
TapImmune Inc.,
Glynn Wilson, Ph.D.
Chairman & CEO
+1-866-359-7541
Exhibit 99.3
TapImmune Presents New Data at San Antonio Breast Cancer Symposium Showing Robust Generation of T-Cell Immunity
PR Newswire
JACKSONVILLE, Florida, December 10, 2015
JACKSONVILLE, Florida, December 10, 2015 /PRNewswire/ --
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Vaccination with TPIV 100 boosts T-cell immunity to HER2 in HER2+ Breast Cancer Patients
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Provides catalyst to start Phase II studies
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TapImmune, Inc. (TPIV), a clinical-stage onco-immunology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, today presented new data at the San Antonio Breast Cancer Symposium in the poster titled, "Robust generation of T-cell immunity to HER2 in HER2+ breast cancer patients with a degenerate subdominant HLA-DR epitope vaccine." The poster was co-authored by Dr. Wilson, Dr. Knutson, Dr Degnim and other researchers from the Mayo Clinic in Rochester, Minnesota and presented by Dr. Glynn Wilson of TapImmune and Dr. Amy Degnim MD of the Mayo Clinic.
Results showing that 90% of patients produce robust T-cell immunity suggest that TPIV 100 may be useful in several therapeutic applications including: prevention of disease recurrence when administered following standard-of-care treatment in women with no evidence of disease; administered as a combination therapy including in HER2 metastatic patients; and used before surgery to potentially induce tumor regression.
"These encouraging data provide the rationale and catalyst for TapImmune to start Phase II clinical trials on TPIV 100," stated Dr. Glynn Wilson, Chairman and CEO of TapImmune. "There is a clear and unmet need for more efficacious treatment in a larger population of HER2+ breast cancer patients and the data show TPIV 100 has the potential to address this need through several different therapeutic applications, pre, post and in conjunction with current standard of care treatments."
These data show the Phase I results on TPIV 100, a vaccine containing 4 Class II HER2neu antigens. In summary, vaccination generates T-cell immunity to naturally processed HER2neu antigens. Responses to the individual peptide antigens was high (ranging from 68-88%), which led to the majority (90%) of patients generating T-cells that recognized naturally processed antigens, a clear improvement over previous vaccines with more limited utility. Elevated T-cell frequency to HER2 was observed 3 months after the last vaccination demonstrating memory immunity. Antibody immunity to HER2 was modestly increased in vaccinated patients.
About TapImmune Inc.
TapImmune Inc. is an immunotherapy company specializing in the development of innovative technologies for the treatment of cancer, including metastasis, and infectious disease. The Company's peptide or nucleic acid-based immunotherapeutics, 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 using proprietary nucleic acid-based expression systems. The Company's technologies may be used as stand-alone medications or in combination with current treatment modalities. Please visit the Company's website at www.tapimmune.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, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update the forward-looking statements.
Contacts:
TapImmune Inc.,
Glynn Wilson, Ph.D.
Chairman & CEO
+1-866-359-7541