Kura Oncology Reports Fourth Quarter and Full Year 2016 Operational and Financial Results
March 14 2017 - 4:05PM
Kura Oncology, Inc., (NASDAQ:KURA) a clinical stage
biopharmaceutical company focused on the development of precision
medicines for oncology, today reported fourth quarter and full year
2016 financial results and provided a corporate update.
“Our precision medicine approach continues to deliver results,
and we are pleased to have achieved important milestones in each of
our programs,” said Troy Wilson, Ph.D., J.D., President and CEO of
Kura Oncology. “We are encouraged by the durability of responses
observed in patients with HRAS mutant squamous cell carcinomas of
the head and neck treated with tipifarnib, and believe our data
validate HRAS as a driver oncogene in that disease. In our Phase 2
trial in PTCL, we have observed initial signals of clinical
activity and identified potential biomarkers, including genes that
are expressed and/or altered, which appear to be associated with
the activity of tipifarnib. In our Phase 2 trial of tipifarnib in
lower-risk MDS, based on anecdotal evidence of hematological
improvement observed in several patients, we have amended the study
to evaluate further dose regimens in an effort to optimize those
initial findings. With KO-947, our ERK inhibitor, we anticipate
initiating the Phase 1 study, and through preclinical studies have
identified potential development opportunities, including KRAS and
BRAF mutant cancers and squamous cell carcinomas. We also selected
a development candidate in our menin-MLL inhibitor program, KO-539,
which demonstrates potent anti-tumor activity in certain
preclinical models of acute leukemia.”
Recent Operational Highlights
- Selection of KO-539, an orally-available small molecule
inhibitor of the menin-MLL interaction, as a development candidate
for the treatment of mixed lineage leukemias, a genetically-defined
subset of the two most common forms of acute leukemia, acute
myeloid leukemia and acute lymphoblastic leukemia
- FDA acceptance of an Investigational New Drug (IND) application
to begin Phase 1 clinical testing of KO-947, a small molecule
inhibitor of extracellular-signal-regulated kinases 1 and 2
(ERK1/2) as a treatment for cancers in which the mitogen activated
protein kinase (MAPK) pathway is dysregulated
- Appointment of Steven H. Stein, M.D., to Kura’s board of
directors. Dr. Stein currently serves as Executive Vice President
and Chief Medical Officer of Incyte Corporation and has
extensive experience in the discovery, development and
commercialization of oncology therapeutics.
- First patient dosed in Phase 2 clinical trial of tipifarnib in
patients with chronic myelomonocytic leukemia (CMML)
- Presentation of preclinical data highlighting the
characterization of KO-947, and preclinical data relating to the
identification and optimization of potent and selective inhibitors
of the menin-MLL interaction. Both presentations took place at the
EORTC-NCI-AACR Symposium on Molecular Targets and Cancer
Therapeutics in Munich, Germany.
Upcoming Potential Milestones and Expectations for
Clinical and Preclinical Programs
- Initiation of the Phase 1 clinical trial for KO-947 during the
first half of 2017
- Data from the first and second stages of the Phase 2 trial of
tipifarnib in peripheral T-cell lymphomas (PTCL) and associated
biomarkers in the first half of 2017
- Preclinical data for KO-947 and KO-539 in the first half of
2017
- Additional data from the Phase 2 trial of tipifarnib in HRAS
mutant squamous cell carcinomas of the head and neck (SCCHN) during
the second half of 2017
- Additional preclinical and clinical data for tipifarnib in PTCL
in the second half of 2017
- Data from the Phase 2 tipifarnib trials in lower risk
myelodysplastic syndromes (MDS) and in CMML during the first half
of 2018
Financial Results for the Fourth Quarter and the Full
Year 2016
- Cash, cash equivalents and short-term investments totaled $67.8
million as of December 31, 2016, compared with $74.6 million as of
September 30, 2016 and $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 the second half of 2018.
- Research and development expenses for the fourth quarter of
2016 were $5.5 million, compared to $5.1 million for the fourth
quarter of 2015. Research and development expenses for the full
year 2016 were $20.4 million, compared to $17.8 million for the
prior year.
- General and administrative expenses for the fourth quarter of
2016 were $2.0 million, compared to $1.7 million for the fourth
quarter of 2015. General and administrative expenses for the full
year 2016 were $8.0 million, compared to $6.1 million for the prior
year.
- Net loss for the fourth quarter of 2016 was $7.3 million,
compared to a net loss of $6.5 million for the fourth quarter of
2015. Net loss for the full year 2016 was $27.6 million, compared
to a net loss of $22.6 million for the prior year.
Conference Call and Webcast
Kura’s management will host a webcast and conference call
regarding this announcement at 4:30 p.m. EDT today. The live call
may be accessed by dialing (877) 516-3514 for domestic callers and
(281) 973-6129 for international callers and using conference ID #
84483740. A live webcast of the call will be available from the
investor relations section of the company website at
www.kuraoncology.com, and will be archived there for 30 days. 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 ID # 84483740.
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
molecule drug candidates 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 pipeline
includes KO-947, an ERK inhibitor, and KO-539, an inhibitor of the
menin-MLL protein-protein interactions. 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 and KO-947, 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. Factors that may cause actual results to
differ materially include the risk that compounds that appeared
promising in early research or clinical trials do not demonstrate
safety and/or efficacy in later preclinical 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,
risks associated with reliance on third parties to successfully
conduct clinical trials, 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. You are urged to consider statements that include
the words "may," "will," "would," "could," "should," "believes,"
"estimates," "projects," "promise, " "potential," "expects,"
"plans," "anticipates," "intends," "continues," "designed," "goal,"
or the negative of those words or other comparable words to be
uncertain and forward-looking. For a further list and description
of the risks and uncertainties the Company faces, please refer to
the Company'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.
|
|
KURA ONCOLOGY, INC. |
|
Statements of Operations Data |
|
(unaudited) |
|
(in thousands, except per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Operating
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
5,503 |
|
|
$ |
5,113 |
|
|
$ |
20,404 |
|
|
$ |
17,777 |
|
General
and administrative |
|
|
1,975 |
|
|
|
1,729 |
|
|
|
7,963 |
|
|
|
6,088 |
|
Total
operating expenses |
|
|
7,478 |
|
|
|
6,842 |
|
|
|
28,367 |
|
|
|
23,865 |
|
Other
income, net |
|
|
131 |
|
|
|
368 |
|
|
|
807 |
|
|
|
1,240 |
|
Net
loss |
|
$ |
(7,347 |
) |
|
$ |
(6,474 |
) |
|
$ |
(27,560 |
) |
|
$ |
(22,625 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.38 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.47 |
) |
|
$ |
(2.28 |
) |
Weighted
average number of shares used in computing net loss per
share, basic and diluted |
|
|
19,153 |
|
|
|
15,262 |
|
|
|
18,701 |
|
|
|
9,933 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KURA ONCOLOGY, INC. |
|
Balance Sheet Data |
|
(unaudited) |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2016 |
|
|
2015 |
|
Cash,
cash equivalents and short-term investments |
|
$ |
67,790 |
|
|
$ |
85,746 |
|
Working
capital |
|
|
63,359 |
|
|
|
81,814 |
|
Total
assets |
|
|
69,821 |
|
|
|
87,259 |
|
Long-term
liabilities |
|
|
7,494 |
|
|
|
101 |
|
Accumulated deficit |
|
|
(53,856 |
) |
|
|
(26,296 |
) |
Stockholders’ equity |
|
|
56,876 |
|
|
|
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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