Conference Call and Live Audio Webcast Scheduled for Today, April 5, 2018, at 4:30 p.m. ET
Recent Corporate and Clinical Developments:
- Published long-term immune response and progression-free survival data from completed Phase 1 clinical study of TPIV200
- Commenced dosing in 280-patient, grant-funded Phase 2 study of TPIV200 in women with advanced TNBC
- Enhanced IP portfolio for PolyStart™ technology, expanding to cover any polypeptide sequences comprising poly-antigen arrays (PAAs)
- Appointed Dr. Richard Kenney as Acting Chief Medical Officer
Upcoming Anticipated Milestones:
- Q3 2018: Report interim immune response data from ongoing Phase 2 TNBC
- 2H 2018: Report interim results from ongoing Phase 2 study of TPIV200 in combination with AstraZeneca’s durvalumab in patients with platinum-resistant ovarian cancer
- 2018: Mayo Clinic to initiate Phase 1b/2a study of TPIV100 in women with HER2/neu+ ductal carcinoma in situ (DCIS) breast cancer
- 1Q 2019: Report interim safety and futility results from Phase 2 ovarian cancer study
JACKSONVILLE, FLORIDA – April 5, 2018 – TapImmune Inc. (NASDAQ: TPIV), a leading clinical-stage immuno-oncology company with ongoing clinical trials in ovarian and breast cancer, today provided its business update for the fourth quarter and year-end 2017. A public conference call and live audio webcast is scheduled for today at 4:30 p.m. ET.
“Throughout 2017, we made significant advances toward achieving our goals and reaching our milestones,” said Peter Hoang, President and CEO of TapImmune. “We recently announced the publication of new clinical data for our multi-epitope T-cell vaccine targeting folate receptor alpha, TPIV200, in patients with ovarian and breast cancer. In this publication we showed an encouraging potential progression-free survival benefit in women with ovarian cancer in their first remission, which we are currently exploring further in an ongoing randomized Phase 2 study. Should we see a similar, prolonged PFS in this larger study, we believe that TPIV200 could have a viable pathway toward potential approval in this indication, for which it has FDA Fast Track designation. We remain on track to conduct an interim safety and futility analysis for the Phase 2 study by mid-2019.”
Mr. Hoang continued, “With multiple Phase 2 and Phase 1/2 clinical studies ongoing, several of which are funded by U.S. Department of Defense grants, and our preclinical PolyStart™ technology maturing rapidly to the point where it may drive value through strategic partnership, we believe TapImmune is on a strong growth trajectory that will continue through 2018 and beyond. Our progress will be measured by continued milestone execution and we look forward to building value at each step along the way.”
Current Clinical Studies:
TPIV200: Lead T-cell vaccine targeting folate receptor alpha
- FDA Fast-tracked Phase 2 maintenance therapy study in platinum-sensitive ovarian cancer
TapImmune is currently enrolling women who have completed initial therapy with a platinum regimen and are in first remission. Enrollment remains on track with projections and the company plans to conduct a blinded interim safety and futility analysis once the data from the first half of enrollment is achieved and responses mature, which is currently expected by mid-2019. This program benefits from FDA Fast Track and 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. Enrollment in this study is complete and TapImmune expects to report interim immune response data in the third quarter 2018.
- U.S. Department of Defense (DoD)-funded Phase 2 efficacy study in advanced triple-negative breast cancer
In late 2017, the Mayo Clinic successfully dosed the first patient in a Phase 2 study designed to evaluate the safety and efficacy of TPIV200 in prolonging disease-free survival in women with advanced triple-negative breast cancer. This 280-patient randomized, double-blind and placebo-controlled study is completely funded by a $13.3 million grant from the U.S. DoD.
- Memorial Sloan Kettering-sponsored Phase 2 combination study with AstraZeneca’s durvalumab in platinum-resistant ovarian cancer
Data from the first 27 patients enrolled in the study are currently being analyzed by the study’s clinical investigators at MSKCC. TapImmune anticipates reporting the results based on these 27 patients once patient analysis at MSKCC is released.
Planned Clinical Studies:
TPIV100/110 T-cell vaccine targeting HER2/neu:
- Mayo Clinic is expected to initiate a Phase 1b/2a study of TPIV100 in women with an early form of breast cancer called ductal carcinoma in situ (DCIS). This study is also fully funded by a grant from the U.S. DoD. If successful, TapImmune’s HER2/neu-targeted vaccine may complement standard surgery and chemotherapy.
- TapImmune planned to submit FDA filings for its five-peptide HER2 vaccine, TPIV110, and begin a Phase 1/2 clinical study in women with HER2-low breast cancer. In the fourth quarter, the U.S. DoD expressed interest in fully funding a larger Phase 2 clinical study using TPIV110 in combination with Herceptin® (trastuzumab) in HER2neu+ breast cancer. TapImmune is currently engaged in discussions with the Mayo Clinic and the U.S. DoD regarding this Phase 2 study, which would supplant the previously planned TapImmune-sponsored Phase 1/2 study. TapImmune will provide an update once the details of the study and the required FDA filings are finalized.
Conference Call and Webcast Information:
To access the live conference call on April 5, 2018, at 4:30pm ET you may use:
- (855) 238-2333 (U.S.)
- (412) 317-5215 (International)
To access the live audio webcast, visit the Events section of the TapImmune website http://markertherapeutics.com/events. The webcast will also be archived for 90 days beginning at approximately 6:30 p.m. ET, on April 5, 2018.
TapImmune, Inc. is a leader in the TapImmune Inc. is a leader in the development of novel immunotherapies for cancer, with multiple Phase 2 and Phase 1b/2 clinical studies currently ongoing for the treatment of ovarian and breast cancer. The company's peptide- or nucleic acid-based immunotherapeutic products comprise multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patient's killer T-cells and helper T-cells, and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems. This unique approach can produce off-the-shelf T-cell vaccine candidates that elicit a broad-based T-cell response and can be given without respect to HLA type. The company's technologies may be used as stand-alone medications or in combination with other treatment modalities.
For additional information, please call toll free at (904) 862-6490 or visit: tapimmune.com
To receive future press releases via email, please visit: https://tapimmune.com/investors/email-alerts/
Follow us on Twitter @Tapimmune_Inc, or follow us on Facebook.
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.
Aaron Santos
investor.relations@tapimmune.com
(904) 862-6490 EXT. 102
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D. (Investors)
(212) 375-2664
jdrumm@tiberend.com
David Schemelia (Media)
(212) 375-2686
dschemelia@tiberend.com
TAPIMMUNE INC.
CONSOLIDATED BALANCE SHEETS
| December 31, 2017 | December 31, 2016 | |
| ASSETS | ||
| Current assets: | ||
| Cash | $5,129,289 | $7,851,243 |
| Prepaid expenses and deposits | 51,150 | 70,149 |
| Total current assets | 5,180,439 | 7,921,392 |
| Total assets | $5,180,439 | $7,921,392 |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
| Current liabilities: | ||
| Accounts payable and accrued liabilities | $1,508,312 | $1,224,940 |
| Research agreement obligations | – | 492,365 |
| Warrant liability | 9,000 | 14,500 |
| Promissory note | 5,000 | 5,000 |
| Total current liabilities | 1,522,312 | 1,736,805 |
| Total liabilities | 1,522,312 | 1,736,805 |
| COMMITMENTS AND CONTINGENCIES | ||
| Stockholders’ equity: | ||
| Preferred stock – $0.001 par value, 5 million shares authorized at December 31, 2017 and 2016, respectively | ||
| Series A, $0.001 par value, 1.25 million shares designated, 0 shares issued and outstanding as of December 31, 2017 and 2016, respectively | – | – |
| Series B, $0.001 par value, 1.5 million shares designated, 0 shares issued and outstanding as of December 31, 2017 and 2016, respectively | – | – |
| Common stock, $0.001 par value, 41.7 million shares authorized, 10.6 million and 8.4 million shares issued and outstanding as of December 31, 2017 and 2016, respectively | 10,616 | 8,421 |
| Additional paid-in capital | 161,067,538 | 151,991,974 |
| Accumulated deficit | (157,420,027) | (145,815,808) |
| Total stockholders’ equity | 3,658,127 | 6,184,587 |
| Total liabilities and stockholders’ equity | $5,180,439 | $7,921,392 |
TAPIMMUNE INC.
CONSOLIDATED STATEMENT OF OPERATIONS
| For the Years Ended | ||
| December 31, 2017 | December 31, 2016 | |
| OPERATING EXPENSES | ||
| Research and development | $5,250,985 | $3,800,035 |
| General and administrative | 6,412,121 | 4,692,234 |
| Total operating expenses | 11,663,106 | 8,492,269 |
| Loss from operations | (11,663,106) | (8,492,269) |
| OTHER INCOME (EXPENSE) | ||
| Change in fair value of warrant liabilities | 5,500 | 5,939,500 |
| Debt extinguishment gain | 492,365 | – |
| Grant income | 183,064 | 231,200 |
| Loss on debt settlement agreements | – | (135,640) |
| Other income | – | 1,828 |
| NET LOSS | $(10,982,177) | $(2,455,381) |
| Basic net loss per share | $(1.16) | $(0.36) |
| Diluted net loss per share | $(1.16) | $(0.72) |
| Weighted average number of common shares outstanding, basic | 9,453,483 | 6,889,898 |
| Weighted average number of common shares outstanding, diluted | 9,453,483 | 7,420,995 |
TAPIMMUNE INC.
CONSOLIDATED STATEMENT OF CASH FLOWS
| For the Years Ended | ||
| December 31, 2017 | December 31, 2016 | |
| CASH FLOWS FROM OPERATING ACTIVITIES | ||
| Net loss | $(10,982,177) | $(2,455,381) |
| Reconciliation of net loss to net cash used in operating activities: | ||
| Changes in fair value of warrant liabilities | (5,500) | (5,939,500) |
| Shares issued in debt settlement agreements | – | 70,315 |
| Stock-based compensation | 2,738,244 | 1,558,409 |
| Debt extinguishment gain | (492,365) | – |
| Changes in operating assets and liabilities: | ||
| Prepaid expenses and deposits | 18,999 | (1,346) |
| Accounts payable and accrued expenses | 283,372 | 257,582 |
| Net cash used in operating activities | (8,439,427) | (6,509,921) |
| CASH FLOWS FROM FINANCING ACTIVITIES | ||
| Proceeds from issuance of common stock and warrants in private placement, net of offering costs | 5,408,343 | 2,331,126 |
| Proceeds from exercise of stock warrants, net of offering costs | 619,623 | 5,483,349 |
| Proceeds from exercise of stock options | – | 18,125 |
| Repayment of promissory note | – | (25,000) |
| Repayment of promissory note – related party | – | (23,000) |
| Repurchase of common stock to pay for employee withholding taxes | (310,493) | – |
| Net cash provided by financing activities | 5,717,473 | 7,784,600 |
| Net (decrease) increase in cash | (2,721,954) | 1,274,679 |
| Cash at beginning of period | 7,851,243 | 6,576,564 |
| CASH AT END OF PERIOD | $5,129,289 | $7,851,243 |
