Kura Oncology Reports Second Quarter 2020 Financial Results
August 06 2020 - 3:05PM
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
second quarter 2020 financial results and provided a corporate
update.
“Last quarter we implemented a number of strategic measures to
focus on our two major development pillars: tipifarnib in
HRAS-dependent head and neck squamous cell carcinoma (HNSCC) and
KO-539 in acute myeloid leukemia (AML),” said Troy Wilson, Ph.D.,
J.D., President and Chief Executive Officer of Kura Oncology.
“We believe tipifarnib and KO-539 provide opportunities to address
large proportions of head and neck cancers and acute leukemias,
respectively. Now, following a successful public offering this past
quarter, we are well-positioned to advance each of these programs
toward important upcoming catalysts.”
Corporate Update
- Encouraging progress in Phase 1/2A trial of menin
inhibitor, KO-539 – KO-539 is a potent and small molecule
inhibitor of the menin-KMT2A(MLL) protein-protein interaction, with
the potential to target at least 35% of patients with AML. A Phase
1/2A clinical trial of KO-539 in patients with relapsed/refractory
AML (KOMET-001) continues in dose escalation. Kura remains focused
on its goal of reaching a recommended Phase 2 dose and schedule,
after which it intends to open expansion cohorts in NPM1-mutant and
KMT2A(MLL)-rearranged AML – selected patient populations where
KO‑539 has the potential to demonstrate increased clinical benefit.
The Company intends to submit an abstract for preliminary data
presentation of the KO-539 program at the American Society of
Hematology Annual Meeting in December 2020, and continues to add
clinical sites to the trial in anticipation of moving into the
expansion cohorts.
- Updated data from Phase 2 trial of tipifarnib in HRAS
mutant HNSCC – Kura reported updated clinical outcome data
from a Phase 2 clinical trial of tipifarnib in patients with
recurrent or metastatic HRAS mutant HNSCC (RUN-HN) at the American
Society of Clinical Oncology (ASCO) Virtual Scientific Program in
May 2020. The data showed a median overall survival of 15.4 months,
median progression-free survival of 5.9 months and an overall
response rate of 50% among the 18 evaluable patients. Outcomes for
three FDA-approved therapies for HNSCC are poor, with reported
median OS of 5-8 months, PFS of 2-3 months and ORR of 13-16% in the
second line. These data further support the Company’s efforts in
HRAS mutant HNSCC, a disease of high unmet need.
- Expanded enrollment in registration-directed trial of
tipifarnib – Kura has amended its ongoing
registration-directed trial of tipifarnib (AIM-HN) to enroll all
recurrent or metastatic HNSCC patients with HRAS mutations,
regardless of variant allele frequency, expanding the proportion of
patients who are being treated in the trial. The primary outcome
measure for AIM-HN remains overall response rate in patients with
high HRAS mutant variant allele frequency. The amendment enables
the Company to assess the potential clinical benefit of tipifarnib
in the overall HRAS mutant HNSCC population as well.
- Expansion opportunity for tipifarnib in HRAS and PI3K
dependent tumors – Based upon the unmet need and
encouraging preclinical data, Kura is prioritizing the clinical
development of tipifarnib in combination with a PI3K alpha
inhibitor as a strategy to treat HNSCC patients whose tumors
overexpress the HRAS protein, as well as those with PI3K dependent
tumors. These patients may represent significant subsets of HNSCC
patients with distinct biology that may be targeted by tipifarnib,
which is supported by observed activity in multiple models and in
each of these subsets in preclinical studies. The Company believes
that the total addressable population for tipifarnib may be as high
as 50% of HNSCC.
Financial Results
- Research and development expenses for the second quarter of
2020 were $13.7 million, compared to $11.4 million for the second
quarter of 2019.
- General and administrative expenses for the second quarter of
2020 were $7.5 million, compared to $4.5 million for the second
quarter of 2019.
- Net loss for the second quarter of 2020 was $20.5 million,
compared to a net loss of $14.9 million for the second quarter of
2019.
- Cash, cash equivalents and short-term investments totaled
$338.9 million as of June 30, 2020, including net proceeds of
approximately $134.9 million from a public offering completed in
May 2020, compared with $236.9 million as of December 31,
2019.
- Management expects that current cash, cash equivalents and
short-term investments will be sufficient to fund current
operations into 2023.
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, August 6, 2020, to discuss
the financial results for the second quarter 2020 and provide a
corporate update. The live call may be accessed by dialing (866)
278-7953 for domestic callers and +1 (323) 347-3281 for
international callers and entering the conference code: 1697775. 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 two wholly
owned 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 most advanced drug candidate is
tipifarnib, a potent, selective and orally bioavailable farnesyl
transferase inhibitor currently in a registration-directed trial
(AIM-HN) in patients with recurrent or metastatic HRAS mutant
HNSCC. The Company’s pipeline is also highlighted by KO-539, a
potent and selective inhibitor of the menin-KMT2A(MLL)
protein-protein interaction currently in a Phase 1/2A clinical
trial (KOMET-001) in patients with relapsed/refractory AML. 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 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, applications and
other interactions with regulatory bodies, the risks associated
with reliance on third parties to successfully conduct clinical
trials, the risks associated with reliance on outside financing to
meet capital requirements, the risks associated with the COVID-19
global pandemic, 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 |
|
|
Six Months
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
13,697 |
|
|
$ |
11,440 |
|
|
$ |
26,272 |
|
|
$ |
21,822 |
|
General and administrative |
|
|
7,476 |
|
|
|
4,451 |
|
|
|
15,101 |
|
|
|
9,020 |
|
Total operating expenses |
|
|
21,173 |
|
|
|
15,891 |
|
|
|
41,373 |
|
|
|
30,842 |
|
Other income, net |
|
|
686 |
|
|
|
948 |
|
|
|
1,676 |
|
|
|
1,959 |
|
Net loss |
|
$ |
(20,487 |
) |
|
$ |
(14,943 |
) |
|
$ |
(39,697 |
) |
|
$ |
(28,883 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.40 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.82 |
) |
|
$ |
(0.75 |
) |
Weighted average number of shares used in computing net
loss per share, basic and diluted |
|
|
51,633 |
|
|
|
38,928 |
|
|
|
48,522 |
|
|
|
38,550 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KURA
ONCOLOGY, INC. |
|
Balance
Sheet Data |
|
(unaudited) |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
Cash, cash equivalents and short-term investments |
|
$ |
338,869 |
|
|
$ |
236,891 |
|
Working capital |
|
|
323,635 |
|
|
|
224,039 |
|
Total assets |
|
|
353,000 |
|
|
|
241,972 |
|
Long-term liabilities |
|
|
12,075 |
|
|
|
7,627 |
|
Accumulated deficit |
|
|
(252,574 |
) |
|
|
(212,877 |
) |
Stockholders’ equity |
|
|
322,374 |
|
|
|
218,781 |
|
Contacts
Company:Pete De SpainVice President, Investor Relations
&Corporate Communications(858)
500-8803pete@kuraoncology.com
Investors:Robert H. UhlManaging DirectorWestwicke ICR(858)
356-5932robert.uhl@westwicke.com
Media:Jason SparkManaging DirectorCanale Communications(619)
849-6005jason@canalecomm.com
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