Kura Oncology Reports Fourth Quarter and Full Year 2018 Financial Results
March 05 2019 - 03:03PM
– Registration-directed trial of tipifarnib in
HRAS mutant HNSCC underway –
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
fourth quarter and full year 2018 financial results and provided a
corporate update.
“I am very pleased with the progress we have made over the past
year, highlighted by the initiation of our registration-directed
trial of tipifarnib in HRAS mutant head and neck squamous cell
carcinoma (HNSCC),” said Troy Wilson, Ph.D., J.D., President and
Chief Executive Officer of Kura Oncology. “In addition, we
have made considerable strides toward broadening the clinical
utility of tipifarnib, showing proof-of-concept in
angioimmunoblastic T-cell lymphoma (AITL), validating CXCL12 as a
therapeutic target in peripheral T-cell lymphoma (PTCL) and
identifying a potential association between CXCL12 expression and
clinical benefit in pancreatic cancer. Together, these efforts are
helping us to expand the opportunity for tipifarnib beyond HRAS
mutant solid tumors and into additional indications of high unmet
need.”
“As we begin 2019, we believe Kura is well positioned, with
additional data from three ongoing Phase 2 trials of tipifarnib
expected throughout the year and an emerging pipeline that includes
KO-947, an ERK inhibitor with Phase 1 data expected later this
year, and KO-539, a menin-MLL inhibitor that is anticipated to
enter the clinic next quarter. We look forward to providing updates
on each of our programs during the year as we continue to execute
on our initial registration-directed trial.”
Recent Highlights
- New findings for tipifarnib in pancreatic
cancer – In January 2019, Kura presented new findings at
the 2019 Gastrointestinal Cancers Symposium identifying a potential
association between CXCL12 expression and clinical benefit in
patients with pancreatic cancer treated with tipifarnib. Elevated
CXCL12 expression is known to be a poor prognostic factor in
patients with certain solid tumors, including pancreatic cancer.
The Company is currently working with key opinion leaders and
investigators on the design of a proof-of-concept trial in this
indication.
- Validation of CXCL12 as a therapeutic target of
tipifarnib in PTCL – In December 2018, Kura reported an
association between CXCL12 expression and clinical benefit in the
Phase 2 trial of tipifarnib in relapsed or refractory PTCL at the
American Society of Hematology (ASH) Annual Meeting. Specifically,
patients with a high ratio of expression of CXCL12 to its receptor
CXCR4 experienced a 50% objective response rate (five of 10 with
either complete response or partial response) and a 90% clinical
benefit rate (nine of 10, including stable disease) with
tipifarnib. Patients in the Phase 2 trial were heavily pretreated,
with a median of three prior lines of therapy (range
1-7).
- Proof-of-concept in AITL – Kura also reported
preliminary data from its Phase 2 clinical trial of tipifarnib in
patients with relapsed or refractory PTCL at ASH. As of the
November 21, 2018 data cutoff date, a total of 39 patients were
enrolled in the trial, including 19 patients with AITL, an
aggressive form of PTCL often characterized by high levels of
CXCL12 expression. Of the 13 evaluable AITL patients, two achieved
a complete response and four achieved a partial response, for an
objective response rate of 46%, meeting the pre-specified primary
efficacy endpoint for the AITL cohort.
- New AITL patent strengthens intellectual property
protection for tipifarnib – In November 2018, Kura
announced the issuance of U.S. Patent No. 10,137,121, which
includes multiple claims directed to the use of tipifarnib as a
method of treating patients with AITL. The patent has an expiration
date of November 2037, excluding any possible patent term
extension. The AITL patent was issued just six months after a U.S.
patent was issued for the use of tipifarnib as method of treating
patients with certain CXCL12-expressing cancers, namely PTCL and
acute myeloid leukemia (AML). Kura continues to pursue U.S. and
foreign patent protection in these and other
indications.
- Continued progress in dose-escalation trial of
KO-947 – KO-947 is a potent and selective small molecule
inhibitor of extracellular signal related kinase (ERK), which Kura
is advancing as a potential treatment for patients with tumors that
have dysregulated activity due to mutations or other mechanisms in
the mitogen-activated protein kinase (MAPK) pathway. The Company
continues to evaluate a number of doses and schedules for KO-947
and anticipates having data from its Phase 1 clinical trial in
2019.
- Investigational new drug (IND) cleared for
KO-539 – KO-539 is a potent and selective small molecule
inhibitor of the menin-mixed lineage leukemia (menin-MLL)
protein-protein interaction. Kura has generated preclinical data
that support the potential anti-tumor activity of KO-539 in
genetically defined subsets of acute leukemia. The U.S. Food and
Drug Administration (FDA) has cleared Kura’s IND application and
the Company anticipates initiating a Phase 1 clinical trial of
KO-539 in relapsed or refractory AML in the second quarter of
2019.
Financial Results
- Research and development expenses for the fourth quarter of
2018 were $12.1 million, compared to $8.1 million for the fourth
quarter of 2017. Research and development expenses for the full
year 2018 were $46.8 million, compared to $26.4 million for the
prior year.
- General and administrative expenses for the fourth quarter of
2018 were $4.6 million, compared to $2.9 million for the fourth
quarter of 2017. General and administrative expenses for the full
year 2018 were $16.1 million, compared to $9.7 million for the
prior year.
- Net loss for the fourth quarter of 2018 was $16.1 million,
compared to a net loss of $10.7 million for the fourth quarter of
2017. Net loss for the full year 2018 was $60.4 million, compared
to a net loss of $35.4 million for the prior year. Net loss for the
fourth quarter and full year of 2018 included non-cash, share-based
compensation expense of $1.7 million and $8.7 million,
respectively, compared to $1.4 million and $4.5 million for the
same periods in 2017, respectively.
- Cash, cash equivalents and short-term investments totaled
$179.0 million as of December 31, 2018, compared with $93.1 million
as of December 31, 2017.
- Management expects that current cash, cash equivalents and
short-term investments will be sufficient to fund its current
operations into 2021.
Upcoming Milestones
- Additional data from the ongoing Phase 2 trial of tipifarnib in
PTCL, including duration of response data from the AITL cohort and
additional data from the CXCL12-high PTCL cohort, in
mid-2019
- Additional data from the ongoing Phase 2 trial of tipifarnib in
HRAS mutant solid tumors, including HNSCC and other squamous cell
carcinomas (SCCs), in the second half of 2019
- Additional data from the ongoing Phase 2 trial of tipifarnib in
chronic myelomonocytic leukemia (CMML) in 2019
- Additional data on the molecular mechanisms of action of
tipifarnib in 2019
- Data from the Phase 1 dose-escalation trial of KO-947 in
2019
- Initiation of the Phase 1 clinical trial of KO-539 in the
second quarter of 2019
Conference Call and Webcast
Kura’s management will host a webcast and conference call today
at 4:30 p.m. ET / 1:30 p.m. PT today, March 5, 2019, to discuss the
financial results for the fourth quarter and full year 2018 and
provide a corporate update. 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: 8996475. A
live webcast of the call will be available from the Investors and
Media section of the Company’s website at www.kuraoncology.com, and
will be archived there for 30 days.
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’s lead drug candidate is tipifarnib, a
farnesyl transferase inhibitor, for which the Company has initiated
a registration-directed trial of tipifarnib in recurrent or
metastatic patients with HRAS mutant HNSCC. In addition, tipifarnib
is being evaluated in multiple other Phase 2 clinical trials in
solid tumor and hematologic indications. Kura’s pipeline also
includes KO-947, an ERK inhibitor, currently in a Phase 1
dose-escalation trial, and KO-539, a menin-MLL inhibitor, which is
anticipated to enter into a Phase 1 clinical trial in the second
quarter of 2019. For additional information about Kura, 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’s product candidates, tipifarnib, KO-947 and
KO-539, progress and expected timing of Kura’s drug development
programs and clinical trials and submission of regulatory filings,
the presentation of data from clinical trials, plans regarding
regulatory filings and future clinical trials, the regulatory
approval path for tipifarnib, the strength of Kura’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 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 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, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
12,084 |
|
|
$ |
8,119 |
|
|
$ |
46,787 |
|
|
$ |
26,426 |
|
General and administrative |
|
|
4,550 |
|
|
|
2,876 |
|
|
|
16,096 |
|
|
|
9,651 |
|
Total operating expenses |
|
|
16,634 |
|
|
|
10,995 |
|
|
|
62,883 |
|
|
|
36,077 |
|
Other income, net |
|
|
537 |
|
|
|
247 |
|
|
|
2,436 |
|
|
|
643 |
|
Net
loss |
|
$ |
(16,097 |
) |
|
$ |
(10,748 |
) |
|
$ |
(60,447 |
) |
|
$ |
(35,434 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.42 |
) |
|
$ |
(0.37 |
) |
|
$ |
(1.72 |
) |
|
$ |
(1.52 |
) |
Weighted
average number of shares used in computing net loss per
share, basic and diluted |
|
|
38,079 |
|
|
|
29,234 |
|
|
|
35,191 |
|
|
|
23,237 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KURA
ONCOLOGY, INC. |
|
Balance
Sheet Data |
|
(unaudited) |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
Cash, cash equivalents and
short-term investments |
|
$ |
178,985 |
|
|
$ |
93,145 |
|
Working capital |
|
|
167,582 |
|
|
|
84,610 |
|
Total assets |
|
|
182,379 |
|
|
|
95,851 |
|
Long-term liabilities |
|
|
7,779 |
|
|
|
5,955 |
|
Accumulated deficit |
|
|
(149,737 |
) |
|
|
(89,290 |
) |
Stockholders’ equity |
|
|
160,985 |
|
|
|
79,865 |
|
Contacts
Company:Pete De SpainVice President, Investor Relations
&Corporate Communications(858)
500-8803pete@kuraoncology.com
Investors:Robert H. UhlManaging DirectorWestwicke Partners,
LLC(858) 356-5932robert.uhl@westwicke.com
Media:Jason SparkManaging DirectorCanale Communications(619)
849-6005jason@canalecomm.com
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