Kura Oncology Reports Third Quarter 2016 Financial Results
November 07 2016 - 4:05PM
Kura Oncology, Inc., (Nasdaq:KURA) a clinical stage
biopharmaceutical company committed to realizing the promise of
precision medicines for the treatment of cancer, today reported
third quarter 2016 financial results and recent business
highlights.
“During the third quarter, we have continued to advance our
tipifarnib development program,” said Troy Wilson, Ph.D., J.D.,
President and CEO of Kura Oncology. “Our Phase 2 HRAS solid tumor
trial is progressing and the two patients from stage 1 with partial
responses have now been on study for 15 months and 8 months, which
is encouraging given the relatively limited clinical benefit these
patients observed on prior therapy. We have focused the second
stage of the trial on patients with HRAS mutant squamous cell head
and neck cancer, and we look forward to additional results in this
patient population.”
“In addition, our trials in PTCL and lower-risk MDS are ongoing,
and we recently initiated our planned Phase 2 trial for tipifarnib
in patients with CMML,” stated Dr. Wilson. “We believe each of
these Phase 2 studies has a strong scientific and clinical
rationale, and they provide multiple potential opportunities for
registration-enabling studies.”
Dr. Wilson continued, “We are preparing to advance our ERK
inhibitor, KO-947, into clinical testing and are encouraged by the
consistent and compelling activity we have observed in preclinical
models of cancers with mutations or dysregulation of the MAPK
pathway as well as by our identification of potential biomarkers to
guide development. I am very pleased we are on track to submit an
IND before year-end.”
Upcoming Clinical and Preclinical Activities for Kura
Oncology Programs
- Submission of the investigational new drug (IND) for KO-947 is
anticipated in the fourth quarter of 2016.
- Nomination of a development candidate for the menin-MLL program
is anticipated in the fourth quarter of 2016.
- Presentation of preclinical data for KO-947 and menin-MLL
program at EORTC in Munich in November 2016.
- Initiation of a Phase 1 study for KO-947 is anticipated in the
first half of 2017.
- Topline data from the Phase 2 study of tipifarnib in PTCL is
anticipated in the first half of 2017.
- Additional data from the Phase 2 study of tipifarnib in HRAS
mutant tumors is anticipated in the first half of 2017.
Financial Results for the Third Quarter
2016
- Cash, cash equivalents and short-term investments totaled $74.6
million as of September 30, 2016, compared with $85.7 million as of
December 31, 2015. Management expects that current cash, cash
equivalents and short-term investments will be sufficient to fund
current operations into 2018.
- Research and development expenses for the third quarter of 2016
were $5.3 million, compared to $4.6 million for the third quarter
of 2015.
- General and administrative expenses for the third quarter of
2016 were $1.7 million, compared to $1.8 million for the third
quarter of 2015.
- Net loss for the third quarter of 2016 was $6.9 million, or
$0.37 per share, compared to a net loss of $6.1 million, or $0.57
per share, for the third quarter of 2015.
Webcast and Conference Call
Kura management will host a webcast and conference call
regarding this announcement at 1:30 p.m. PST/4:30 p.m. EST today.
The live call may be accessed by dialing 877-516-3514 for domestic
callers and 281-973-6129 for international callers and entering the
conference code: 10990522. A live webcast and archive of the call
will be available online from the investor relations section of the
company website at www.kuraoncology.com. A telephone replay of the
call will be available by dialing 855-859-2056 for domestic callers
or 404-537-3406 for international callers and entering the
conference code: 10990522.
About Kura Oncology
Kura Oncology is a clinical-stage biopharmaceutical company
committed to realizing the promise of precision medicines for the
treatment of cancer. The company’s pipeline consists of small
molecules that target cancer signaling pathways where there is a
strong scientific and clinical rationale to improve outcomes by
identifying those patients most likely to benefit from treatment.
Kura Oncology’s lead drug candidate is tipifarnib, a farnesyl
transferase inhibitor, which is currently being studied in multiple
Phase 2 clinical trials. The preclinical pipeline includes KO-947,
an ERK inhibitor, and a menin-MLL program. For additional
information about Kura Oncology, please visit the company’s website
at www.kuraoncology.com.
Forward Looking Statements
This news release contains certain forward-looking statements
that involve risks and uncertainties that could cause actual
results to be materially different from historical results or from
any future results expressed or implied by such forward-looking
statements. Such forward-looking statements include statements
regarding, among other things, the efficacy, safety and therapeutic
potential of Kura Oncology’s product candidates and compounds,
including tipifarnib, progress and expected timing of Kura
Oncology’s drug development programs and clinical trials, plans
regarding regulatory filings and future research and clinical
trials, the strength of Kura Oncology’s balance sheet and the
adequacy of cash on hand. You are urged to consider statements that
include the words “may,” “will,” “would,” “could,” “believes,”
“estimates,” “projects,” “potential,” “expects,” “plans,”
“anticipates,” “intends,” “continues,” “designed,” “goal,” or the
negative of those words or other comparable words to be uncertain
and forward-looking. These forward-looking statements are based
upon Kura Oncology’s current expectations 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, which include, without limitation,
the risk that compounds that appeared promising in early studies or
clinical trials do not demonstrate safety and/or efficacy in later
studies or clinical trials, the risk that Kura Oncology may not
obtain approval to market its product candidates, uncertainties
associated with performing clinical trials, regulatory filings and
applications, the risks associated with reliance on outside
financing to meet capital requirements, and other risks associated
with the process of discovering, developing and commercializing
drugs that are safe and effective for use as human therapeutics,
and in the endeavor of building a business around such drugs. For a
further list and description of the risks and uncertainties Kura
Oncology faces, please refer to Kura Oncology’s periodic and other
filings with the Securities and Exchange Commission, which are
available at www.sec.gov. Such forward-looking statements are
current only as of the date they are made, and Kura Oncology
assumes no obligation to update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
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|
KURA
ONCOLOGY, INC. |
|
Statements
of Operations Data |
|
(unaudited) |
|
(in thousands,
except per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
Nine Months
Ended |
|
|
|
|
|
September 30, |
|
|
September 30, |
|
|
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
$ |
5,316 |
|
|
$ |
4,635 |
|
|
$ |
14,901 |
|
|
$ |
12,664 |
|
General and administrative |
|
|
|
|
1,742 |
|
|
|
1,793 |
|
|
|
5,988 |
|
|
|
4,359 |
|
Total operating expenses |
|
|
|
|
7,058 |
|
|
|
6,428 |
|
|
|
20,889 |
|
|
|
17,023 |
|
Other income, net |
|
|
|
|
132 |
|
|
|
338 |
|
|
|
676 |
|
|
|
872 |
|
Net loss |
|
|
|
$ |
(6,926 |
) |
|
$ |
(6,090 |
) |
|
$ |
(20,213 |
) |
|
$ |
(16,151 |
) |
Net loss per share,
basic and diluted |
|
|
|
$ |
(0.37 |
) |
|
$ |
(0.57 |
) |
|
$ |
(1.09 |
) |
|
$ |
(1.98 |
) |
Weighted average number
of shares used in computing net loss per share,
basic and diluted |
|
|
|
|
18,850 |
|
|
|
10,723 |
|
|
|
18,549 |
|
|
|
8,136 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KURA
ONCOLOGY, INC. |
|
Balance
Sheet Data |
|
(unaudited) |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
|
|
2016 |
|
|
2015 |
|
Cash, cash equivalents and short-term
investments |
|
|
|
$ |
74,568 |
|
|
$ |
85,746 |
|
Working capital |
|
|
|
|
70,443 |
|
|
|
81,814 |
|
Total assets |
|
|
|
|
76,304 |
|
|
|
87,259 |
|
Long-term liabilities |
|
|
|
|
7,366 |
|
|
|
101 |
|
Accumulated deficit |
|
|
|
|
(46,509 |
) |
|
|
(26,296 |
) |
Total stockholders’ equity |
|
|
|
|
63,666 |
|
|
|
82,103 |
|
|
|
|
|
|
|
|
|
|
|
|
CONTACT INFORMATION
INVESTOR CONTACT:
Robert H. Uhl
Managing Director
Westwicke Partners, LLC
(858) 356-5932
robert.uhl@westwicke.com
CORPORATE COMMUNICATIONS CONTACT:
Mark Corbae
Vice President
Canale Communications
(619) 849-5375
mark@canalecomm.com
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