TapImmune Provides Fourth Quarter and Year-End 2017 Corporate and Clinical Update
April 5, 2018
Conference Call and Live Audio Webcast Scheduled for Today, April 5, 2018, at 4:30 p.m. ET
[/vc_column_text][vc_column_text]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
- 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
- FDA Fast-tracked Phase 2 maintenance therapy study in platinum-sensitive ovarian cancer
- Multi-center Phase 2 dosing study in triple-negative breast cancer
- U.S. Department of Defense (DoD)-funded Phase 2 efficacy study in advanced triple-negative breast cancer
- Memorial Sloan Kettering-sponsored Phase 2 combination study with AstraZeneca’s durvalumab in platinum-resistant ovarian cancer
- 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.
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- (412) 317-5215 (International)
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 |