Kura Oncology Reports Second Quarter 2023 Financial Results
03 Agosto 2023 - 5:05PM
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 2023 financial results and provided a corporate
update.
“With its safety, tolerability and clinical activity profile, we
believe ziftomenib has the ideal properties to become part of the
backbone of acute myeloid leukemia (AML) therapy across the
continuum of patient care,” said Troy Wilson, Ph.D., J.D.,
President and Chief Executive Officer of Kura Oncology. “Our
confidence in the program is strengthened by the late-breaking
clinical data presented at the European Hematology Association
(EHA) Annual Congress in June, which showed one of the highest
response rates reported for a targeted therapy in the setting of
relapsed/refractory AML. Building on momentum generated by these
data, enrollment in our Phase 2 registration-directed trial of
ziftomenib in patients with relapsed/refractory NPM1-mutant AML
continues to outperform our projections, an indication of both the
size of this population and its significant unmet need. In
addition, we are now treating NPM1-mutant and KMT2A-rearranged AML
patients with ziftomenib in combination with chemotherapy- and
venetoclax-based regimens, and we look forward to sharing
preliminary data from this first combination study later this year
or early next.”
Recent Highlights
- Late-breaking clinical data for ziftomenib in
NPM1-mutant AML – In June, Kura reported updated data from
the KOMET-001 trial of ziftomenib, including durable activity in
patients with heavily pretreated and co-mutated relapsed/refractory
NPM1-mutant AML. The data were featured during a late-breaking oral
session at the EHA Annual Congress in Frankfurt. As of an April
12th data cutoff, seven of the 20 patients with NPM1-mutant AML
treated at the recommended Phase 2 dose (RP2D) of 600 mg achieved
complete remission (CR) with full count recovery, for a CR rate of
35% and an overall response rate of 45%. An eighth patient, who had
a CR with partial count recovery after treatment with ziftomenib,
subsequently evolved to a CR with full count recovery after stem
cell transplant and remained on study as of the EHA presentation.
In addition, a patient with NPM1-mutant AML treated at 200 mg
remained on ziftomenib for 36 cycles as of the cutoff date. The
median duration of response for all NPM1-mutant patients was 8.2
months, with a median follow-up of 8.8 months. Continuous
once-daily dosing of ziftomenib was well tolerated in the Phase 1
trial and the reported adverse event profile remained consistent
with features of underlying disease.
- Enrollment in registration-directed trial of ziftomenib
continues to outperform projections – Enrollment in Kura’s
Phase 2 registration-directed trial of ziftomenib in NPM1-mutant
relapsed or refractory AML continues to outperform the Company’s
projections. The trial is expected to enroll a total of 85 patients
in the U.S. and Europe, with a primary endpoint of CR or CR with
partial hematologic recovery (CRh). 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.
- Multiple patients dosed in combination study of
ziftomenib in NPM1-mutant and KMT2A-rearranged AML – Kura
is conducting a series of studies to evaluate ziftomenib in
combination with current standards of care in earlier lines of
therapy and across multiple patient populations. The Company is now
dosing patients in the first of its combination studies, KOMET-007,
in patients with NPM1-mutant and KMT2A-rearranged AML in the newly
diagnosed and relapsed/refractory settings.
KOMET-007 is a Phase 1 study designed to assess safety,
tolerability and preliminary activity of ziftomenib in combination
with venetoclax/azacitidine (ven/aza) or standard induction
cytarabine/daunorubicin chemotherapy (7+3). Kura anticipates having
preliminary data from the KOMET-007 study in the fourth quarter of
2023 or first quarter of 2024.
- Continued evidence of clinical activity observed with
tipifarnib plus alpelisib in PIK3CA-dependent HNSCC –
Previously, Kura reported the first demonstration of a durable
clinical response with the combination of its farnesyl transferase
inhibitor (FTI) tipifarnib and the PI3K alpha inhibitor alpelisib
in PIK3CA-mutant head and neck squamous cell carcinoma (HNSCC). In
the meantime, dose escalation in the Company’s KURRENT-HN trial of
tipifarnib and alpelisib has continued, with ongoing evidence of
clinical activity at multiple doses and no dose-limiting toxicities
to date. Kura is now evaluating patients in the trial’s highest
planned dose cohort to inform selection of the optimal biologically
active dose for the combination, after which the Company intends to
initiate a small dose expansion of patients with PIK3CA-mutant
HNSCC to validate the safety profile and activity of the
combination at the RP2D. Head and neck cancer is the seventh most
common cancer worldwide and remains a significant unmet need, with
no approved small molecule targeted therapies.
- First-in-human study of KO-2806 to begin in second half
of 2023 – KO-2806 is a next-generation inhibitor of
farnesyl transferase designed to improve upon potency,
pharmacokinetic and physicochemical properties of earlier FTI drug
candidates. Earlier this year, Kura received FDA clearance of its
Investigational New Drug application for KO-2806. Site activation
has now begun in a Phase 1 dose-escalation trial of KO-2806
(FIT-001) and the Company expects to dose the first patients in the
second half of 2023. Concurrent with dose escalation as a
monotherapy, Kura also plans to evaluate KO-2806 in dose escalation
combination cohorts in advanced solid tumors, beginning with clear
cell renal cell carcinoma (ccRCC).
Financial Results
- Research and development expenses for the second quarter of
2023 were $28.2 million, compared to $24.3 million for the second
quarter of 2022.
- General and administrative expenses for the second quarter of
2023 were $11.8 million, compared to $11.1 million for the second
quarter of 2022.
- Net loss for the second quarter of 2023 was $37.2 million,
compared to a net loss of $34.8 million for the second quarter of
2022. This includes non-cash share-based compensation expense of
$7.0 million, compared to $6.5 million for the same period in
2022.
- As of June 30, 2023, Kura had cash, cash equivalents and
short-term investments of $477.0 million, compared to $438.0
million as of December 31, 2022. This includes net proceeds of
approximately $93.6 million from the Company’s public offering
completed in June 2023.
- Based on its operating plan, management expects that cash, cash
equivalents and short-term investments will fund current operations
to mid-2026.
Forecasted Milestones
- Dose the first patients in the KOMET-008 trial of ziftomenib in
combination with additional standards of care, including the FLT3
inhibitor gilteritinib, in the second half of 2023.
- Preliminary data from the KOMET-007 trial of ziftomenib in
combination with ven/aza or 7+3 in the fourth quarter of 2023 or
first quarter of 2024.
- Dose the first patients in the ziftomenib post-transplant
maintenance program in the first quarter of 2024.
- Initiate dose expansion in the KURRENT-HN trial of tipifarnib
and alpelisib in mid-2024.
- Dose the first patients in the FIT-001 monotherapy
dose-escalation trial of KO-2806 as a monotherapy in the second
half of 2023.
- Dose the first patients in the FIT-001 dose-escalation trial of
KO-2806 in combination with a targeted therapy in ccRCC in the
second half of 2024.
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, August 3, 2023, to discuss the
financial results for the second quarter 2023 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: 26884460. 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 is a once-daily, oral drug candidate targeting the
menin-KMT2A protein-protein interaction for the treatment of
genetically defined AML patients with high unmet need. Kura is
currently enrolling patients in a Phase 2 registration-directed
trial of ziftomenib in NPM1-mutant relapsed or refractory AML
(KOMET-001). The Company is also conducting a series of studies to
evaluate ziftomenib in combination with current standards of care,
beginning with venetoclax/azacitidine and standard induction
cytarabine/daunorubicin chemotherapy in NPM1-mutant and
KMT2A-rearranged newly diagnosed and relapsed/refractory AML
(KOMET-007). 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 preparing to
evaluate KO-2806, a next-generation FTI, in a Phase 1
dose-escalation trial as a monotherapy and in combination with
other targeted therapies, beginning with ccRCC (FIT-001). For
additional information, please visit Kura’s website at
www.kuraoncology.com and follow us on Twitter 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 into mid-2026.
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 |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
28,182 |
|
|
$ |
24,258 |
|
|
$ |
53,374 |
|
|
$ |
45,171 |
|
General and administrative |
|
|
11,821 |
|
|
|
11,075 |
|
|
|
23,195 |
|
|
|
22,944 |
|
Total operating expenses |
|
|
40,003 |
|
|
|
35,333 |
|
|
|
76,569 |
|
|
|
68,115 |
|
Other income, net |
|
|
2,829 |
|
|
|
564 |
|
|
|
5,326 |
|
|
|
893 |
|
Net loss |
|
$ |
(37,174 |
) |
|
$ |
(34,769 |
) |
|
$ |
(71,243 |
) |
|
$ |
(67,222 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.53 |
) |
|
$ |
(0.52 |
) |
|
$ |
(1.03 |
) |
|
$ |
(1.01 |
) |
Weighted average number of shares used in computing net loss per
share, basic and diluted |
|
|
69,795 |
|
|
|
66,672 |
|
|
|
69,103 |
|
|
|
66,639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KURA ONCOLOGY, INC. |
|
Balance Sheet Data |
|
(unaudited) |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Cash, cash equivalents and short-term investments |
|
$ |
476,979 |
|
|
$ |
437,985 |
|
Working capital |
|
|
461,747 |
|
|
|
422,369 |
|
Total assets |
|
|
494,737 |
|
|
|
456,306 |
|
Long-term liabilities |
|
|
11,160 |
|
|
|
11,971 |
|
Accumulated deficit |
|
|
(640,051 |
) |
|
|
(568,808 |
) |
Stockholders’ equity |
|
|
459,678 |
|
|
|
420,278 |
|
|
|
|
|
|
|
|
|
|
Contacts
Investors: Pete De Spain Executive Vice President, Investor
Relations & Corporate Communications(858) 500-8803
pete@kuraoncology.com
Media:Alexandra WeingartenSenior Manager, Corporate
Communications(858) 500-8822alexandra@kuraoncology.com
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