Kura Oncology Reports First Quarter 2019 Financial Results and Highlights Upcoming Milestones
May 07 2019 - 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
first quarter 2019 financial results and highlighted upcoming
milestones.
“We have made considerable progress over the past quarter, as we
continue to execute against our first registration-directed trial
for tipifarnib in patients with HRAS mutant squamous head and neck
cancers,” said Troy Wilson, Ph.D., J.D., President and Chief
Executive Officer of Kura Oncology. “Meanwhile, our
elucidation of the CXCL12 pathway as a therapeutic target of
tipifarnib, coupled with identification of associated farnesylated
proteins, offers the potential to significantly expand the
population of patients who may benefit from treatment with
tipifarnib. Ultimately, we believe that CXCL12 pathway biomarkers
could enable registrational strategies for tipifarnib in multiple
hematologic and solid tumor indications.”
“Now, we look forward to a series of important milestones,”
continued Dr. Wilson, “beginning with an update from our ongoing
Phase 2 trial of tipifarnib in angioimmunoblastic T-cell lymphoma
(AITL) and CXCL12-positive peripheral T-cell lymphoma (PTCL), which
was accepted for oral presentation at both the European Hematology
Association (EHA) Annual Congress and the International Conference
on Malignant Lymphoma (ICML) next month. This will be followed by
additional data from our ongoing Phase 2 trial of tipifarnib in
HRAS mutant solid tumors, including head and neck squamous cell
carcinoma (HNSCC) and other squamous cell carcinomas (SCCs), as
well as an update from our ongoing Phase 2 trial in chronic
myelomonocytic leukemia (CMML) later in the year.”
Recent Highlights
- Registration-directed trial of tipifarnib in HRAS
mutant HNSCC – Kura’s global, multi-center, open-label,
non-comparative registration-directed trial of tipifarnib continues
on track. The clinical trial has two cohorts: A non-interventional
screening and outcomes cohort (SEQ-HN) and a treatment cohort
(AIM-HN). AIM-HN is designed to enroll at least 59 evaluable
patients with HRAS mutant HNSCC who have received prior
platinum-based therapy. AIM-HN initiated in November 2018 and is
expected to take approximately two years to fully
enroll.
- Farnesylated proteins associated with CXCL12
expression – In April 2019, Kura reported new findings at
the American Association for Cancer Research (AACR) Annual Meeting
suggesting that gene expression of the exclusively farnesylated
proteins RHOE and PRICKLE2 is strongly associated with CXCL12
expression in bone marrow stroma. These findings provide key
evidence supporting the inhibition of the CXCL12 pathway as a
mechanism of action mediating the activity of tipifarnib and other
farnesyl transferase inhibitors.
- Potential expansion to other CXCL12+ lymphoma
indications – Kura reported additional findings at AACR
identifying CXCL12 expression as a potential biomarker of clinical
benefit in patients with diffuse large B-cell lymphoma (DLBCL) as
well as mycosis fungoides, the most common form of cutaneous T-cell
lymphoma (CTCL). The results were obtained from an analysis of a
subset of samples from a previously conducted Phase 2 trial of
tipifarnib in patients with relapsed and refractory lymphomas and
are consistent with similar findings from the Company in other
indications such as PTCL, acute myeloid leukemia (AML) and
pancreatic cancer.
- Emerging pipeline of clinical-stage drug
candidates – Kura is advancing two additional pipeline
programs: KO-947, a small molecule inhibitor of extracellular
signal-related kinase (ERK), and KO-539, a potent and selective
small molecule inhibitor of the menin-mixed lineage leukemia
(menin-MLL) interaction. The Company continues to evaluate dosing
regimens for KO-947 and anticipates having data from its Phase 1
clinical trial later this year. Meanwhile, the U.S. Food and Drug
Administration (FDA) has cleared the investigational new drug (IND)
application for KO-539 and the Company is preparing to initiate a
Phase 1 clinical trial in patients with relapsed or refractory AML
in mid-2019.
Financial Results
- Research and development expenses for the first quarter of 2019
were $10.4 million, compared to $11.6 million for the first quarter
of 2018.
- General and administrative expenses for the first quarter of
2019 were $4.6 million, compared to $3.4 million for the first
quarter of 2018.
- Net loss for the first quarter of 2019 was $13.9 million,
compared to $14.6 million for the first quarter of 2018.
- Cash, cash equivalents and short-term investments totaled
$165.5 million as of March 31, 2019, compared with $179.0 million
as of December 31, 2018.
- Management expects that current cash, cash equivalents and
short-term investments will be sufficient to fund 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-positive PTCL cohort, at EHA and
ICML in June 2019
- Additional data on biomarkers associated with elevated CXCL12
expression at EHA and ICML in June 2019
- Additional data from the ongoing Phase 2 trial of tipifarnib in
HRAS mutant solid tumors, including HNSCC and other SCCs, in the
second half of 2019
- Additional data from the ongoing Phase 2 trial of tipifarnib in
CMML 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
mid-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, May 7, 2019, to discuss the
financial results for the first quarter 2019 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: 4436235. 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 has
been cleared to begin a Phase 1 clinical trial. 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 potential expansion of tipifarnib to additional indications,
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.
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|
|
|
|
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KURA
ONCOLOGY, INC. |
|
Statements
of Operations Data |
|
(unaudited) |
|
(in thousands,
except per share data) |
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
March 31, |
|
|
2019 |
|
|
2018 |
|
Operating Expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
10,382 |
|
|
$ |
11,566 |
|
General and administrative |
|
4,569 |
|
|
|
3,425 |
|
Total operating expenses |
|
14,951 |
|
|
|
14,991 |
|
Other income, net |
|
1,011 |
|
|
|
387 |
|
Net loss |
$ |
(13,940 |
) |
|
$ |
(14,604 |
) |
Net loss per share, basic and diluted |
$ |
(0.37 |
) |
|
$ |
(0.46 |
) |
Weighted average number of shares used in computing net
loss per share, basic and diluted |
|
38,168 |
|
|
|
31,829 |
|
|
|
|
|
|
|
|
|
|
|
|
|
KURA
ONCOLOGY, INC. |
|
Balance
Sheet Data |
|
(unaudited) |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
|
Cash, cash equivalents and short-term investments |
$ |
165,525 |
|
|
$ |
178,985 |
|
Working capital |
|
155,443 |
|
|
|
167,582 |
|
Total assets |
|
169,617 |
|
|
|
182,379 |
|
Long-term liabilities |
|
7,909 |
|
|
|
7,779 |
|
Accumulated deficit |
|
(163,677 |
) |
|
|
(149,737 |
) |
Stockholders’ equity |
|
149,565 |
|
|
|
160,985 |
|
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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