Kura Oncology Reports First Quarter 2024 Financial Results
May 02 2024 - 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
first quarter 2024 financial results and provided a corporate
update.
“Ziftomenib continues to demonstrate a best-in-class safety and
efficacy profile as well as optimal pharmaceutical properties,
which we believe will enable it to become a cornerstone of therapy
in acute leukemias and beyond,” said Troy Wilson, Ph.D., J.D.,
President and Chief Executive Officer of Kura Oncology. “This
belief is backed by increasing investigator enthusiasm, as
evidenced by rapid enrollment across our ongoing ziftomenib
studies, and further supported by the FDA’s decision to grant
Breakthrough Therapy Designation (BTD) to ziftomenib, making it the
first investigational treatment to be granted BTD for the treatment
of NPM1-mutant acute myeloid leukemia (AML). In the near term, we
look forward to completing enrollment in our registration-directed
trial of ziftomenib in NPM1-mutant AML and working closely with FDA
to bring this potentially innovative medicine to patients in urgent
need of effective treatments.”
Recent Highlights
- Breakthrough Therapy Designation for ziftomenib in
NPM1-mutant AML – Last month, the U.S. Food and Drug
Administration (FDA) granted BTD to ziftomenib for the treatment of
relapsed/refractory (R/R) NPM1-mutant AML. FDA granted BTD based on
data from Kura’s ongoing KOMET-001 trial of ziftomenib in patients
with R/R NPM1-mutant AML. BTD is awarded for a drug that treats a
serious or life-threatening condition and may demonstrate
substantial improvement on one or more clinically significant
endpoints over available therapies.
- Registration-directed trial of ziftomenib in
NPM1-mutant AML nearing completion – Kura remains on track
to complete enrollment of 85 patients in its KOMET-001
registration-directed trial of ziftomenib in NPM1-mutant R/R AML by
mid-2024. In the Phase 1 trial, ziftomenib demonstrated a 35% CR
rate and 45% overall response rate in 20 heavily pretreated
patients with NPM1-mutant AML treated at the recommended Phase 2
dose. NPM1-mutant AML accounts for approximately 30% of new AML
cases annually and represents a disease of significant unmet need
for which no approved targeted therapy exists.
- Positive preliminary combination data for ziftomenib in
NPM1-mutant and KMT2A-rearranged AML – In January 2024,
Kura reported preliminary data from the KOMET-007 dose-escalation
trial of ziftomenib in combination with venetoclax/azacitidine or
cytarabine/daunorubicin (7+3) in patients with NPM1-mutant or
KMT2A-rearranged AML. As of the data cutoff on January 11, 2024,
all five newly diagnosed patients treated with ziftomenib and 7+3
achieved a complete remission (CR) with full count recovery, for a
CR rate of 100%. The overall response rate among the 15 R/R
patients treated with ziftomenib and venetoclax/azacitidine was
53%. Continuous daily dosing of ziftomenib at 200 mg was well
tolerated. No differentiation syndrome events of any grade were
reported, and no dose-limiting toxicities, evidence of QTc
prolongation, drug-drug interactions or additive myelosuppression
were observed. As of the data cutoff, 16 of the first 20 patients
remained on trial, including all 11 NPM1-mutant patients.
- Dose escalation continues in KOMET-007 combination
trial of ziftomenib – To date, the 400 mg dose of
ziftomenib has been cleared in three of the four cohorts in the
KOMET-007 trial: 1) in combination with venetoclax/azacitidine in
R/R NPM1-mutant AML, 2) in combination with venetoclax/azacitidine
in R/R KMT2A-rearranged AML and 3) in combination with 7+3 in newly
diagnosed adverse risk NPM1-mutant AML. Enrollment at the 600 mg
dose is ongoing in all three cohorts. Enrollment continues at the
400 mg dose in combination with 7+3 in newly diagnosed adverse risk
KMT2A-rearranged AML.
- First patients dosed in KOMET-008 combination trial of
ziftomenib – In February, Kura began dosing patients in
its KOMET-008 trial of ziftomenib in combination with additional
standards of care, including the FLT3 inhibitor gilteritinib,
FLAG-IDA or LDAC, for the treatment of R/R NPM1-mutant or
KMT2A-rearranged AML. Preclinical data for ziftomenib in
combination with FLT3 inhibitors demonstrate strong synergistic
effects compared to either single agent alone. Roughly half of
patients with R/R NPM1-mutant AML have co-occurring FLT3 mutations,
and the prognosis for these patients is poor.
- First patients dosed with KO-2806 and cabozantinib in
renal cell carcinoma – In March, Kura announced dosing of
the first patient with KO-2806, the Company’s next-generation
farnesyl transferase inhibitor (FTI), in combination with
cabozantinib in clear cell renal cell carcinoma, just four months
after dosing the first patients with KO-2806 as a monotherapy in
the FIT-001 dose-escalation trial. The Company remains on track to
dose the first patient in combination with adagrasib in
KRASG12C-mutated non-small cell lung cancer by the middle of this
year, as dose escalation of KO-2806 as a monotherapy continues in
parallel.
Financial Results
- Research and development expenses for the first quarter of 2024
were $36.3 million, compared to $25.2 million for the first quarter
of 2023.
- General and administrative expenses for the first quarter of
2024 were $18.2 million, compared to $11.4 million for the first
quarter of 2023.
- Net loss for the first quarter of 2024 was $49.5 million,
compared to a net loss of $34.1 million for the first quarter of
2023. This included non-cash share-based compensation expense of
$8.5 million, compared to $6.8 million for the same period in
2023.
- As of March 31, 2024, Kura had cash, cash equivalents and
short-term investments of $527 million, compared to $424 million as
of December 31, 2023. This includes net proceeds of approximately
$145.8 million from the Company’s private placement in January
2024.
- Based on its operating plan, management expects that cash, cash
equivalents and short-term investments will fund current operations
into 2027.
Forecasted Milestones
- Complete enrollment of 85 patients in the KOMET-001
registration-directed trial of ziftomenib in NPM1-mutant R/R AML by
mid-2024.
- Identify the recommended Phase 2 dose of ziftomenib in
combination with venetoclax and azacitidine by mid-2024.
- Identify the recommended Phase 2 dose of ziftomenib in
combination with 7+3 by mid-2024.
- Initiate Phase 1b expansion study of ziftomenib in combination
with standards of care, including venetoclax/azacitidine in newly
diagnosed NPM1-mutant or KMT2A-rearranged AML, in the second half
of 2024.
- Submit an investigational new drug application for ziftomenib
in a solid tumor indication and present preclinical data at a
medical meeting in the second half of 2024.
- Dose the first patients with KO-2806 and adagrasib in
KRASG12C-mutated non-small cell lung cancer by mid-2024.
- Complete enrollment of two expansion cohorts in KURRENT-HN and
identify the optimal biologically active dose of tipifarnib and
alpelisib by the end of 2024.
- Present data from the KURRENT-HN trial of tipifarnib in
combination with alpelisib in PIK3CA-dependent head and neck
squamous cell carcinoma (HNSCC) in the first half of 2025.
Conference Call and Webcast
Kura’s management will host a webcast and conference call at
4:30 p.m. ET / 1:30 p.m. PT today, May 2, 2024, to discuss the
financial results for the first quarter 2024 and to provide a
corporate update. The live call may be accessed by dialing (888)
886-7786 for domestic callers and (416) 764-8658 for international
callers and entering the conference ID: 20226736. 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.
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.
Ziftomenib, a once-daily, oral drug candidate targeting the
menin-KMT2A protein-protein interaction, has received Breakthrough
Therapy Designation for the treatment of R/R NPM1-mutant AML. Kura
is currently enrolling patients in a Phase 2 registration-directed
trial of ziftomenib in NPM1-mutant R/R AML (KOMET-001). The Company
is also conducting a series of clinical trials to evaluate
ziftomenib in combination with current standards of care in
NPM1-mutant and KMT2A-rearranged newly diagnosed and R/R AML.
Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2
trial in combination with alpelisib for patients with
PIK3CA-dependent HNSCC (KURRENT-HN). Kura is also evaluating
KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial
as a monotherapy and in combination with targeted therapies
(FIT-001). For additional information, please visit Kura’s website
at www.kuraoncology.com and follow us on X and LinkedIn.
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, ziftomenib, tipifarnib and
KO-2806, 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 sufficiency of cash, cash equivalents and short-term
investments to fund its current operating plan to 2027. 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, 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 |
|
|
|
March 31, |
|
|
|
2024 |
|
|
2023 |
|
Operating Expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
36,268 |
|
|
$ |
25,192 |
|
General and administrative |
|
|
18,184 |
|
|
|
11,374 |
|
Total operating expenses |
|
|
54,452 |
|
|
|
36,566 |
|
Other income, net |
|
|
4,927 |
|
|
|
2,497 |
|
Net loss |
|
$ |
(49,525 |
) |
|
$ |
(34,069 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.59 |
) |
|
$ |
(0.50 |
) |
Weighted average number of shares used in computing net
loss per share, basic and diluted |
|
|
83,905 |
|
|
|
68,403 |
|
|
|
|
|
|
|
|
KURA ONCOLOGY, INC. |
|
Balance Sheet Data |
|
(unaudited) |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
Cash, cash equivalents and short-term investments |
|
$ |
527,122 |
|
|
$ |
423,957 |
|
Working capital |
|
|
505,569 |
|
|
|
397,218 |
|
Total assets |
|
|
553,908 |
|
|
|
448,935 |
|
Long-term liabilities |
|
|
16,558 |
|
|
|
16,399 |
|
Accumulated deficit |
|
|
(770,964 |
) |
|
|
(721,439 |
) |
Stockholders’ equity |
|
|
505,084 |
|
|
|
397,273 |
|
|
|
|
|
|
|
|
|
|
Contacts
Investors: Pete De Spain Executive Vice President, Investor
Relations & Corporate Communications(858) 500-8833
pete@kuraoncology.com
Media:Alexandra WeingartenAssociate Director, Investor Relations
& Corporate Communications(858)
500-8822alexandra@kuraoncology.com
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