Kura Oncology Reports Third Quarter 2023 Financial Results
02 Noviembre 2023 - 2:01PM
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
third quarter 2023 financial results and provided a corporate
update.
“I am proud of our team’s considerable progress,
as we continue to execute across all three of our wholly owned,
clinical-stage programs,” said Troy Wilson, Ph.D., J.D., President
and Chief Executive Officer of Kura Oncology. “We believe our lead
drug candidate, ziftomenib, is well positioned for market
leadership, with multibillion dollar global revenue potential in
acute leukemias and beyond. Our conviction is supported by a
growing body of clinical data as a monotherapy and, increasingly,
in combination with standards of care. We continue to be encouraged
by the rapid pace of enrollment in our KOMET-001
registration-directed trial in NPM1-mutant acute myeloid leukemia
(AML), as well as in our KOMET-007 combination trial. We look
forward to sharing preliminary combination data in NPM1-mutant and
KMT2A-rearranged AML early next quarter.”
“Meanwhile,” continued Dr. Wilson, “we continue to
unlock the substantial therapeutic and commercial value of farnesyl
transferase inhibition. We believe the positive results from our
AIM-HN registration-directed trial of tipifarnib and the favorable
safety and tolerability profile of tipifarnib in combination with
alpelisib in our ongoing KURRENT-HN trial significantly de-risk
development of our next-generation farnesyl transferase inhibitor
(FTI), KO-2806. We are pleased to be in the clinic with KO-2806 and
look forward to evaluating it in combination with other targeted
therapies, including adagrasib in KRASG12C-mutated non-small cell
lung cancer (NSCLC) and cabozantinib in clear cell renal cell
carcinoma (ccRCC). If successful, we believe KO-2806 could become
an ideal combination partner for multiple targeted therapies in
large solid tumor indications.”
Recent Highlights
- Rapid pace of enrollment continues in
registration-directed trial of ziftomenib in NPM1-mutant
AML – The KOMET-001 registration-directed trial of
ziftomenib in NPM1-mutant relapsed or refractory AML is expected to
enroll a total of 85 patients in the U.S. and Europe, with a
primary endpoint of complete remission (CR) or CR with partial
hematologic recovery (CRh). In the Phase 1 trial, ziftomenib
demonstrated a 35% CR rate and 45% overall response rate in 20
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. Kura expects to
complete enrollment of all 85 patients in the Phase 2
registration-directed trial no later than mid-2024.
- Preliminary data from KOMET-007 combination trial of
ziftomenib upcoming – KOMET-007 is a Phase 1
dose-escalation study designed to assess safety, tolerability and
preliminary activity of ziftomenib in combination with either: 1)
venetoclax and azacitidine in patients with relapsed/refractory
NPM1-mutant and KMT2A-rearranged AML or 2) standard induction
cytarabine/daunorubicin chemotherapy (7+3) in NPM1-mutant and
KMT2A-rearranged patients in the frontline setting. The Company
expects to share preliminary data from 20 patients in KOMET-007,
including NPM1-mutant and KMT2A-rearranged patients treated with
ziftomenib in the newly diagnosed and relapsed/refractory AML
settings, early in the first quarter of 2024.
- Positive results from AIM-HN registration-directed
trial of tipifarnib in HRAS mutant HNSCC – Kura recently
presented positive results from the AIM-HN registration-directed
trial of tipifarnib as a monotherapy in patients with HRAS mutant
head and neck squamous cell carcinoma (HNSCC). The results were
featured during a late-breaking mini-oral session at the European
Society for Medical Oncology Congress in Madrid. The Company
continues to evaluate whether the combination of tipifarnib and
alpelisib has potential to extend the clinical benefit observed in
the AIM-HN trial to a broader set of HNSCC patients in its ongoing
KURRENT-HN study.
- First patient dosed in FIT-001 dose-escalation study of
KO-2806 – Last month, Kura announced that the first
patient was dosed in its FIT-001 Phase 1 dose-escalation trial of
KO-2806. KO-2806 is a next-generation FTI designed to improve upon
potency, pharmacokinetic and physicochemical properties of earlier
FTI drug candidates. Concurrent with dose escalation as a
monotherapy in the FIT-001 trial, the Company also plans to
evaluate KO-2806 in dose-escalation combination cohorts with
adagrasib in KRASG12C-mutated NSCLC and with cabozantinib in
ccRCC.
- Preclinical data supports clinical combinations of
KO-2806 with adagrasib and cabozantinib – Kura presented
preclinical data at the AACR-NCI-EORTC International Conference on
Molecular Targets and Cancer Therapeutics supporting its rationale
to combine KO-2806 with adagrasib in KRASG12C-mutated NSCLC and
with cabozantinib in ccRCC. The new findings illustrate the
potential for FTIs to drive enhanced antitumor activity and address
mechanisms of innate and adaptive resistance to targeted therapies
such as KRAS inhibitors and tyrosine kinase inhibitors.
- Clinical collaboration with Mirati to evaluate KO-2806
and adagrasib in KRASG12C-mutated
NSCLC – Earlier today, Kura announced a clinical
collaboration and supply agreement with Mirati Therapeutics to
evaluate the combination of KO-2806 and adagrasib in patients with
KRASG12C-mutated NSCLC. Under the terms of the agreement, Kura will
sponsor the Phase 1 study and Mirati will supply adagrasib for the
study. The collaboration highlights the potential to address the
urgent need for more durable and effective treatment options for
patients with cancers driven by the KRASG12C-mutant oncogene.
- Brian Powl appointed as Chief Commercial
Officer – Mr. Powl joined Kura in August 2023 with more
than two decades of experience in building commercial brands in
hematology and oncology, with expertise in developing and executing
patient-focused strategies across sales, marketing and market
access for global biotech and pharmaceutical products, including
extensive global experience in hematologic malignancies.
Financial Results
- Research and development expenses for the third quarter of 2023
were $29.3 million, compared to $25.0 million for the third quarter
of 2022.
- General and administrative expenses for the third quarter of
2023 were $13.1 million, compared to $11.6 million for the third
quarter of 2022.
- Net loss for the third quarter of 2023 was $38.6 million,
compared to a net loss of $35.5 million for the third quarter of
2022. This includes non-cash share-based compensation expense of
$7.1 million, compared to $6.4 million for the same period in
2022.
- As of September 30, 2023, Kura had cash, cash equivalents and
short-term investments of $452.6 million, compared to $438.0
million as of December 31, 2022.
- Based on its operating plan, management expects that cash, cash
equivalents and short-term investments will fund current operations
to mid-2026.
Forecasted Milestones
- Report preliminary data from 20 patients in the KOMET-007 trial
of ziftomenib in combination with venetoclax and azacitidine or 7+3
early in the first quarter of 2024.
- 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 first quarter of 2024.
- Initiate the ziftomenib post-transplant maintenance program in
the first quarter of 2024.
- Complete enrollment of 85 patients in the KOMET-001
registration-directed trial of ziftomenib in NPM1-mutant AML by
mid-2024.
- Determine the optimum biologically active dose for tipifarnib
in combination with alpelisib and determine next steps for the
program by mid-2024.
- Dose the first patients in the FIT-001 dose-escalation trial of
KO-2806 in combination with adagrasib in KRASG12C-mutated NSCLC by
mid-2024.
- Dose the first patients in the FIT-001 dose-escalation trial of
KO-2806 in combination with cabozantinib in ccRCC by mid-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, November 2,
2023, to discuss the financial results for the third 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: 34983466. 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 and
azacitidine and 7+3 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 evaluating KO-2806, a next-generation
FTI, in a Phase 1 dose-escalation trial as a monotherapy and in
combination with adagrasib in KRASG12C-mutated NSCLC and
cabozantinib in ccRCC (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
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 |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
29,328 |
|
|
$ |
24,973 |
|
|
$ |
82,702 |
|
|
$ |
70,144 |
|
General and administrative |
|
|
13,145 |
|
|
|
11,621 |
|
|
|
36,340 |
|
|
|
34,565 |
|
Total operating expenses |
|
|
42,473 |
|
|
|
36,594 |
|
|
|
119,042 |
|
|
|
104,709 |
|
Other income, net |
|
|
3,871 |
|
|
|
1,090 |
|
|
|
9,197 |
|
|
|
1,983 |
|
Net loss |
|
$ |
(38,602 |
) |
|
$ |
(35,504 |
) |
|
$ |
(109,845 |
) |
|
$ |
(102,726 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.50 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.53 |
) |
|
$ |
(1.54 |
) |
Weighted average number of shares used in computing net loss per
share, basic and diluted |
|
|
77,241 |
|
|
|
66,889 |
|
|
|
71,845 |
|
|
|
66,723 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KURA
ONCOLOGY, INC. |
|
Balance
Sheet Data |
|
(unaudited) |
|
(in
thousands) |
|
|
|
|
|
|
|
|
|
|
September
30, |
|
|
December
31, |
|
|
|
2023 |
|
|
2022 |
|
Cash, cash equivalents and short-term investments |
|
$ |
452,593 |
|
|
$ |
437,985 |
|
Working capital |
|
|
432,392 |
|
|
|
422,369 |
|
Total assets |
|
|
473,771 |
|
|
|
456,306 |
|
Long-term liabilities |
|
|
16,309 |
|
|
|
11,971 |
|
Accumulated deficit |
|
|
(678,653 |
) |
|
|
(568,808 |
) |
Stockholders’ equity |
|
|
429,937 |
|
|
|
420,278 |
|
|
|
|
|
|
|
|
|
|
Contacts
Investors: Pete De Spain Executive Vice President,
Investor Relations & Corporate Communications (858) 500-8833
pete@kuraoncology.com
Media: Alexandra Weingarten Senior Manager,
Corporate Communications (858) 500-8822
alexandra@kuraoncology.com
Kura Oncology (NASDAQ:KURA)
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