Conference Call and Live Audio Webcast Scheduled for Today, November 15, 2017, at 4:30 p.m. ET
Recent Corporate and Clinical Developments:
- Appointed Peter Hoang as President and CEO
- Completed enrollment in ongoing Phase 2 dosing study of TPIV200 for treating triple-negative breast cancer (TNBC)
- Began enrolling patients into Phase 2 platinum-sensitive ovarian cancer study under an amended protocol that allows women in their first remission to receive TPIV200 vaccination
- Continued to advance clinical development pipeline in multiple Phase 2 studies in ovarian and breast cancer
Upcoming Anticipated Milestones:
- 2017: Mayo Clinic expected to commence dosing in 280-patient, grant-funded Phase 2 study of TPIV200 in women with advanced TNBC
- 2017: Publish long-term immune response and progression-free survival data from completed Phase 1 clinical study of TPIV200
- 2017: Complete FDA filings required to initiate studies with TPIV 110 for treating HER2/neu+ breast cancer
- 1H 2018: Report interim immune response data from ongoing Phase 2 TNBC
- 1H 2018: Report interim results from ongoing Phase 2 study of TPIV200 in combination with AstraZeneca’s durvalumab in patients with platinum-resistant ovarian cancer
- 1H 2018: Mayo Clinic to initiate Phase 1b/2a study of TPIV100 in women with HER2/neu+ ductal carcinoma in situ (DCIS) breast cancer
JACKSONVILLE, FLORIDA – November 15, 2017 – 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 third quarter 2017. A public conference call and live audio webcast is scheduled for today at 4:30 p.m. ET.
“TapImmune continued to advance its clinical and preclinical programs in the third quarter, which I believe positions us very well to achieve a number of important milestones in 2017 and beyond,” said Peter Hoang, President and CEO of TapImmune. “I believe TapImmune is well positioned to advance immuno-oncology with its broadly effective cancer vaccine candidates and proprietary technologies in the indications and treatment settings we are targeting. Having joined the company in late September, I was drawn to TapImmune because I see an opportunity to lead our industry, in translating the promise of cancer immunotherapy into potentially life-changing therapeutic outcomes.
“As we continue to advance our deep clinical pipeline, I am determined to drive TapImmune to its full potential. Our primary objective is to continue executing on our active Phase 2 trials as efficiently as possible. We and our clinical partners also expect to launch additional clinical studies for each of our novel cancer vaccine candidates in order to further highlight their potential and generate even more value for the company. I believe that driving clinical execution should lead to several significant catalysts for the company and its shareholders over the coming quarters and years. I expect to drive efficiencies from an operational, regulatory and commercial standpoint, so that we achieve every milestone we set for the company. In parallel, my goal is to drive enhanced appreciation and support for TapImmune by the investor community. Finally, I intend to pursue opportunities to bolster our pipeline through strategic corporate and business development initiatives, in an effort to further expand the market opportunity for TapImmune.”
Current Clinical Studies:
TPIV200: Lead T-cell vaccine targeting folate receptor alpha
- 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. TapImmune reached its enrollment target ahead of schedule, and currently expects to report interim immune response data in the first half of 2018.
- 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 in early 2019. This program benefits from FDA Fast Track and Orphan Drug designation.
- 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 in the first half of 2018. If the safety profile remains favorable and there are sufficient signs of tumor response, patient enrollment may resume and the study can be completed as designed.
Planned Clinical Studies:
- Mayo Clinic is expected to commence dosing in a Phase 2 study designed to evaluate the efficacy of TPIV200 in prolonging disease-free survival in women with advanced triple-negative breast cancer. This 280-patient study is planned to commence dosing in the fourth quarter 2017, and is completely funded by a $13.3 million grant from the U.S. Department of Defense.
TPIV100/110 T-cell vaccine targeting HER2/neu:
- TapImmune plans to complete FDA filings required to initiate a Phase 1b/2a clinical study with TPIV110, its five-peptide vaccine candidate for treating women with HER2/neu+ breast 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. Dept. of Defense. If successful, TapImmune’s HER2/neu-targeted vaccine may complement standard surgery and chemotherapy.
Conference Call and Webcast Information:
The company will host a conference call and live audio webcast today, November 15, 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://tapimmune.com/events/. An archive of the webcast and presentation will remain available for 90 days beginning at approximately 6:30 p.m. ET, on November 15, 2017.
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
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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.
(904) 862-6490 EXT. 102
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D. (Investors)
David Schemelia (Media)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||$1,623,302||$1,109,332||$3,815,119||$3,343,248|
|General and administrative||2,549,272||1,612,305||5,167,582||3,557,701|
|Total operating expenses||4,172,574||2,721,637||8,982,701||6,900,949|
|Loss from operations||(4,172,574)||(2,721,637)||(8,982,701)||(6,900,949)|
|Other income (expense):|
|Change in fair value of warrant liabilities||4,000||684,000||8,500||5,925,000|
|Debt extinguishment gain||–||–||492,365||–|
|Loss on debt settlement agreements||–||(65,325)||–||(135,640)|
|Basic net loss per share||$(0.39)||$(0.29)||$(0.91)||$(0.14)|
|Diluted net loss per share||$(0.39)||$(0.29)||$(0.91)||$(0.54)|
|Weighted average number of common shares outstanding, basic||10,219,138||7,281,000||9,081,678||6,370,000|
|Weighted average number of common shares outstanding, diluted||10,219,138||7,281,000||9,081,678||6,935,000|
CONDENSED CONSOLIDATED BALANCE SHEETS
|September 30,||December 31,|
|Prepaid expenses and deposits||96,530||70,149|
|Total current assets||7,704,265||7,921,392|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable and accrued liabilities||$1,757,062||$1,224,940|
|Research agreement obligations||–||492,365|
|Total current liabilities||1,768,062||1,736,805|
|COMMITMENTS AND CONTINGENCIES||–||–|
|Preferred stock – $0.001 par value, 5 million shares authorized at September 30, 2017 and December 31, 2016, respectively|
|Series A, $0.001 par value, 1.25 million shares designated, 0 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively||–||–|
|Series B, $0.001 par value, 1.5 million shares designated, 0 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively||–||–|
|Common stock, $0.001 par value, 41.7 million shares authorized, 10.5 million and 8.4 million shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively||10,539||8,421|
|Additional paid-in capital||160,662,286||151,991,974|
|Total stockholders’ equity||5,936,203||6,184,587|
|Total liabilities and stockholders’ equity||$7,704,265||$7,921,392|
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
|Nine Months Ended|
|Cash Flows from Operating Activities:|
|Reconciliation of net loss to net cash used in operating activities:|
|Changes in fair value of warrant liabilities||(8,500)||(5,925,000)|
|Shares issued in debt settlement agreements||–||70,315|
|Debt extinguishment gain||(492,365)||–|
|Changes in operating assets and liabilities:|
|Prepaid expenses and deposits||(26,381)||(42,849)|
|Accounts payable and accrued expenses||532,122||710,720|
|Net cash used in operating activities||(5,960,981)||(4,756,266)|
|Cash Flows from Financing Activities:|
|Proceeds from issuance of common stock and warrants in private placement, net of offering costs||5,408,343||2,331,126|
|Proceeds from exercise of stock warrants, net of offering costs||619,623||5,483,349|
|Repayment of promissory note||–||(25,000)|
|Repayment of promissory note – related party||–||(23,000)|
|Repurchase of common stock to pay for employee withholding taxes||(310,493)||–|
|Net cash provided by financing activities||5,717,473||7,766,475|
|Net (decrease) increase in cash||(243,508)||3,010,209|
|Cash at beginning of period||7,851,243||6,576,564|
|Cash at end of period||$ 7,607,735||$ 9,586,773|