Kura Oncology Reports Second Quarter 2016 Financial Results
August 10 2016 - 4:03PM
Promising clinical activity observed in Phase 2
trial of tipifarnib in HRAS mutant solid tumors has triggered
additional patient enrollment
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
second quarter 2016 financial results and recent business
highlights. In the company’s Phase 2 trial of tipifarnib in HRAS
mutant solid tumors, positive clinical activity, including
objective responses, has been observed in patients with head and
neck squamous cell carcinomas and patients with salivary gland
cancer. Based on these responses, enrollment will be expanded to an
additional seven patients.
“We are encouraged by the promising activity observed in
patients with HRAS mutant solid tumors that supports the potential
use of tipifarnib as a single agent to inhibit HRAS-mediated
activation of the MAPK pathway to produce therapeutic responses,”
said Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology.
“There are currently no approved treatments that specifically
target HRAS mutations, and the activity we have seen in patients
with HRAS mutant head and neck squamous cell carcinomas is
particularly exciting. I am pleased with Kura’s progress to date in
2016 and look forward to providing additional updates on our
ongoing activities as the year continues to unfold.”
Update on Phase 2 Clinical Trial in HRAS Mutant Solid
Tumors
- Kura Oncology’s Phase 2 trial of tipifarnib in HRAS mutant
solid tumors was designed to initially enroll two cohorts of 11
patients each with HRAS mutations, with the first cohort comprising
patients with thyroid cancers and the second comprising patients
with non-hematologic malignancies other than thyroid cancer. The
primary objective of the study is to investigate the antitumor
activity of tipifarnib in terms of objective response rate.
Secondary objectives include progression-free survival, duration of
response and safety. Per the protocol, two objective responses are
required from the first 11 evaluable patients in a cohort in order
to proceed to the second stage and enroll an additional seven
patients.
- In the second cohort, 11 evaluable patients have been enrolled
to date with the most common histologies comprising salivary gland
tumors (5 patients) and head and neck squamous cell carcinomas (3
patients).
- Among the three patients with HRAS mutant head and neck
squamous cell cancer, two patients have had confirmed partial
responses (PR), and disease stabilization has been observed in the
third patient. The two patients with PR’s have been on study for
more than 12 and 5 months, and responses were seen after 6 and 2
cycles of treatment, respectively. The third patient
demonstrated disease stabilization for 7 months.
- No objective responses have been observed in patients with
salivary gland tumors; however, 3 of 5 salivary gland cancer
patients experienced disease stabilization beyond 6 months (>6,
9 and >11 months).
- The first cohort of the Phase 2 trial, which consists of
patients with thyroid cancers with HRAS mutations, continues
enrolling.
Upcoming Clinical and Preclinical Milestones for Kura
Oncology Programs
- Initiation of a Phase 2 clinical trial for tipifarnib in
patients with CMML is planned in the second half of 2016.
- IND submission for ERK inhibitor, KO-947, is anticipated in the
second half of 2016.
- Nomination of a development candidate for the menin-MLL program
is anticipated in the second half of 2016.
Financial Results for the Second Quarter
2016
- Cash, cash equivalents and short-term investments totaled $80.1
million as of June 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 second quarter of
2016 were $4.9 million, compared to $4.4 million for the second
quarter of 2015.
- General and administrative expenses for the second quarter of
2016 were $1.9 million, compared to $1.5 million for the second
quarter of 2015.
- Net loss for the second quarter of 2016 was $6.7 million, or
$0.36 per share, compared to a net loss of $5.6 million, or $0.54
per share, for the second quarter of 2015.
- During the second quarter of 2016, as previously disclosed,
Kura Oncology put in place a $20.0 million term loan facility, of
which $7.5 million has been drawn to date.
Webcast and Conference Call
Kura management will host a webcast and conference call
regarding this announcement at 1:15 p.m. PDT/4:15 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 entering the
conference code: 60855133. 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: 608855133.
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 being studied in multiple Phase 2
clinical trials. The preclinical pipeline includes KO-947, an ERK
inhibitor, as well as an inhibitor of the menin-MLL interaction.
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, including
the expansion of enrollment, 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.
KURA ONCOLOGY,
INC. |
Statements of
Operations Data |
(unaudited) |
(in thousands, except
per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
Six Months
Ended |
|
|
|
June
30, |
|
|
June
30, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4,936 |
|
|
$ |
4,401 |
|
|
$ |
9,585 |
|
|
$ |
8,029 |
|
General and administrative |
|
|
1,855 |
|
|
|
1,506 |
|
|
|
4,246 |
|
|
|
2,566 |
|
Total operating expenses |
|
|
6,791 |
|
|
|
5,907 |
|
|
|
13,831 |
|
|
|
10,595 |
|
Other income, net |
|
|
130 |
|
|
|
322 |
|
|
|
544 |
|
|
|
534 |
|
Net loss |
|
$ |
(6,661 |
) |
|
$ |
(5,585 |
) |
|
$ |
(13,287 |
) |
|
$ |
(10,061 |
) |
Net loss per share,
basic and diluted |
|
$ |
(0.36 |
) |
|
$ |
(0.54 |
) |
|
$ |
(0.72 |
) |
|
$ |
(1.47 |
) |
Weighted average number
of shares used in computing net loss per share, basic and
diluted |
|
|
18,548 |
|
|
|
10,420 |
|
|
|
18,397 |
|
|
|
6,822 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KURA ONCOLOGY,
INC. |
Balance Sheet
Data |
(unaudited) |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
June
30, |
|
|
December
31, |
|
|
|
2016 |
|
|
2015 |
|
Cash, cash equivalents and short-term
investments |
|
$ |
80,090 |
|
|
$ |
85,746 |
|
Working capital |
|
|
77,037 |
|
|
|
81,814 |
|
Total assets |
|
|
81,744 |
|
|
|
87,259 |
|
Long-term liabilities |
|
|
7,319 |
|
|
|
101 |
|
Accumulated deficit |
|
|
(39,583 |
) |
|
|
(26,296 |
) |
Total stockholders’ equity |
|
|
70,041 |
|
|
|
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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