JACKSONVILLE, Fla.,
April 5, 2018 /PRNewswire/ --
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
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://tapimmune.com/events. The webcast will
also be archived for 90 days beginning at approximately
6:30 p.m. ET, on April 5, 2018.
About TapImmune Inc.
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) that are
designed to comprehensively stimulate a patient's killer T-cells
and helper T-cells, and to restore or further augment antigen
presentation 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 used 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 visit: https://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.
For answers to frequently asked questions, please visit our FAQs
page:
https://tapimmune.com/investors/frequently-asked-questions/
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 results of the Phase II
clinical trials, the ability to obtain regulatory approval of
TPIV200, the Company's ability to raise future financing for
continued development and the ability to successfully commercialize
TPIV200 as well as the risks and uncertainties 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.
– Tables Follow –
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
|
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SOURCE TapImmune Inc.