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| 8-K - PRIMARY DOCUMENT - MABVAX THERAPEUTICS HOLDINGS, INC. | mbvx8k_nov102016.htm |
Exhibit 99.1
MabVax Therapeutics Reports Third Quarter 2016 Financial Results
and
Schedules Conference Call to Provide Corporate Update
On Monday, November 14, 2016
Interim Results of Two Phase I Clinical Trials to be Provided at
time of Conference Call
SAN DIEGO, November 10, 2016
/PRNewswire/ -- MabVax Therapeutics
Holdings, Inc. (NASDAQ: MBVX), today reported on its
financial results for the third quarter ended September 30, 2016,
and schedules a conference call to provide both a business and
financial update on Monday, November 14, 2016, after the close of
the U.S. financial markets. Below are details for the
call.
Business
Update on Interim Results of Clinical Trials and New
Patent
“We look forward to disclosing on Monday the
progress that we have been making with both our clinical trials of
our lead antibody development program,” stated President and
CEO, J. David Hansen. “Specifically, we will be talking about
interim phase I clinical results of MVT-5873 as a therapeutic
antibody for pancreatic cancer and other malignancies that express
the same target antigen present on many gastrointestinal cancers.
We will also share our progress in evaluating the use of MVT-2163
as an immuno-PET imaging agent. And we will explain the
significance of being issued a patent by the United States Patent
and Trademark Office for our fully-human monoclonal
antibody that forms the basis for both
our MVT-5873 and MVT-2163 clinical development
programs.”
Third Quarter 2016 Financial Results
–
Research
and Development expenses totaled $1,671,181, or $1,369,196
excluding stock-based compensation. Research and development
spending was related primarily to our clinical development programs
and sponsored research at Memorial Sloan Kettering Cancer
Center.
–
General
and administrative expenses totaled $2,420,516, or $1,640,161
excluding stock-based compensation and amortization and accretion
related to notes payable. General and administrative spending was
related primarily to business development, investor relations,
facility operating expense and general administration as a public
company.
–
Net
loss attributable to stockholders was $4,357,748, or $0.86 per
share, including $1,082,340 in non-cash items related to
stock-based compensation, amortization and accretion related to
notes payable.
–
At
September 30, 2016, cash and cash equivalents totaled
$6,941,213
Conference
Call Information
When:
November 14, 2016, 4:15 p.m. ET
Dial-in:
(877) 407 – 8293 or (201) 689 - 8349
Conference
ID: MabVax Therapeutics Third Quarter 2016 Conference
Call
Please
join the conference call at least 10 minutes early to
register. A replay of the conference call will be
available for 2 weeks shortly after the call. To access the
replay, please dial 877-660-6853 or 201-612-7415. Conference ID:
13649739.”
About
MabVax Therapeutics Holdings, Inc.
MabVax
Therapeutics Holdings, Inc. is a clinical-stage biotechnology
company focused on the development of antibody-based products to
address unmet medical needs in the treatment of cancer.
MabVax has discovered a pipeline of human monoclonal antibody
products based on the protective immune responses generated by
patients who have been vaccinated against targeted cancers with the
Company's proprietary vaccines. MabVax's HuMab-5B1 antibody
is fully human and was discovered from the immune response of
cancer patients vaccinated with an antigen-specific vaccine during
a Phase I trial at Memorial Sloan Kettering Cancer Center, or
MSK. The antigen the antibody targets is expressed on
more than 90% of pancreatic cancers making the antibody potentially
broadly applicable to most patients suffering from this type of
cancer. Additional information is available at www.mabvax.com.
Forward
Looking Statements:
This
press release contains “forward-looking statements”
regarding matters that are not historical facts, including
statements relating to the company’s progress on clinical
development programs and a receipt by the company of a patent from
the United States Patent and Trademark
Office. We have no assurance that all of the product
development pipeline will be fully developed by the company.
Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or
implied by such forward-looking statements. Words such as
“anticipates,” “plans,”
“expects,” “intends,” “will,”
“potential,” “hope” and similar expressions
are intended to identify forward-looking statements. These
forward-looking statements are based upon current expectations of
the company and involve assumptions that may never materialize or
may prove to be incorrect. Actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of various risks and
uncertainties. Detailed information
regarding factors that may cause actual results to differ
materially from the results expressed or implied by statements in
this press release relating to the company may be found in the
company’s periodic filings with the Securities and Exchange
Commission, or SEC, including the factors described in the section
entitled “Risk Factors” in our annual report on Form
10-K for the fiscal year ended December 31, 2015, as amended and
supplemented from time to time and the Company's Quarterly Reports
on Form 10-Q and other filings submitted by the company to the SEC,
copies of which may be obtained from the SEC's website
at www.sec.gov. These forward-looking statements represent our
judgment as of the time of this release. We do not undertake any
obligation to update forward-looking statements contained in this
press release.
Contact:
Robert
Haag
Managing
Director
IRTH
Communications
MBVX@irthcommunications.com
1-866-976-4784
MabVax Therapeutics Holdings, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
|
|
Three months ended
September 30,
|
Nine months ended
December 31,
|
||
|
|
2016
|
2015
|
2016
|
2015
|
|
Grant
Revenues
|
$—
|
$133,318
|
$148,054
|
$509,474
|
|
Operating
costs & expenses:
|
|
|
|
|
|
Research & development
|
1,671,181
|
3,127,173
|
4,967,695
|
7,178,703
|
|
General & administrative
|
2,420,516
|
2,286,315
|
7,001,521
|
7,473,416
|
|
Total
operating costs & expenses
|
4,091,697
|
5,413,488
|
11,969,216
|
14,652,119
|
|
Loss
from operations
|
(4,091,697)
|
(5,280,170)
|
(11,821,162)
|
(14,142,645)
|
|
Interest
and other expense, net
|
(266,051)
|
(84)
|
(729,331)
|
(269)
|
|
Change
in fair value of warrant liability
|
—
|
—
|
—
|
19,807
|
|
Net
loss
|
$(4,357,748)
|
$(5,280,254)
|
$(12,550,493)
|
$(14,123,107)
|
|
Deemed
dividend on preferred stock and warrants
|
—
|
—
|
—
|
(17,852,921)
|
|
Accretion
of preferred stock dividends
|
—
|
—
|
—
|
(93,234)
|
|
Net
loss allocable to common stockholders
|
$(4,357,748)
|
$(5,280,254)
|
$(12,550,493)
|
$(32,069,262)
|
|
Basic
and diluted net loss per share
|
$(0.86)
|
$(1.51)
|
$(2.87)
|
$(13.96)
|
|
Shares
used to calculate basic & diluted net loss per
share
|
5,041,408
|
3,486,318
|
4,374,801
|
2,297,496
|
MabVax Therapeutics Holdings, Inc.
Condensed Consolidated Balance Sheet Data
|
Assets
|
September 30, 2016
|
December 31, 2015
|
|
|
(Unaudited)
|
Note 1
|
|
Cash & cash equivalents
|
$6,941,213
|
$4,084,085
|
|
Grants
receivable
|
—
|
757,562
|
|
Prepaid expenses & other current assets
|
495,785
|
467,337
|
|
Property & equipment, net
|
665,588
|
135,486
|
|
Goodwill
|
6,826,003
|
6,826,003
|
|
Other long-term assets
|
168,597
|
126,654
|
|
Total
assets
|
$15,097,186
|
$12,397,127
|
|
Total
Accounts payable & other current liabilities
|
4,293,539
|
4,958,363
|
|
Lease
financing obligations & other long-term
liabilities
|
3,289,526
|
—
|
|
Total
equity
|
7,514,121
|
7,438,764
|
|
Total
liabilities & equity
|
$15,097,186
|
$12,397,127
|
Note 1.
The Condensed Consolidated Balance Sheet Data has been derived from
the audited financial statements as of that date.