Kura Oncology Reports Fourth Quarter and Full Year 2022 Financial Results
24 February 2023 - 8:03AM
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
fourth quarter and full year 2022 financial results and provided a
corporate update.
“We continue to have strong conviction in ziftomenib and its
potential to be the best-in-class menin inhibitor,” said Troy
Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura
Oncology. “The speed with which we have begun enrolling patients
with NPM1-mutant acute myeloid leukemia (AML) in our
registration-directed trial speaks to our impressive Phase 1 data
in this population as well as the significant interest in
ziftomenib among investigators. In addition, we believe ziftomenib
is well positioned for future combination strategies, with no
evidence of drug-induced QTc prolongation, no predicted adverse
drug-drug interactions and oral daily dosing that should enable
convenient administration with standards of care. We continue to
prioritize investment in the program and look forward to sharing
further updates as the year progresses, including the presentation
of a more mature dataset from our Phase 1 trial of ziftomenib in
NPM1-mutant AML patients at a medical meeting in mid-2023.”
“Meanwhile, clearance of the IND for KO-2806 marks an important
next step for our next-generation farnesyl transferase inhibitor
(FTI) program,” Dr. Wilson continued. “Our preclinical data is
supportive of FTIs in combination with a growing number of targeted
therapies, including EGFR inhibitors and PI3 kinase alpha
inhibitors as well as tyrosine kinase inhibitors in renal cell
carcinoma and KRAS G12C inhibitors in lung cancer, and we look
forward to starting our first-in-human trial of KO-2806 in the
coming months.”
Recent Highlights
- Updated clinical data from Phase 1 trial of ziftomenib
at ASH – In December, Kura reported updated data from its
Phase 1 trial of ziftomenib, the Company’s potent and selective
menin inhibitor, in an oral presentation at the American Society of
Hematology (ASH) Annual Meeting. The data highlighted the
encouraging safety profile and clinical activity of ziftomenib in
patients with relapsed/refractory AML, including a 30% complete
response (CR) rate with full count recovery among 20 patients with
NPM1-mutant AML treated at the 600 mg dose. Notably, two-thirds of
NPM1-mutant AML patients who achieved a CR at 600 mg had IDH and/or
FLT3 co-mutations, all of whom had failed prior treatment with IDH
and/or FLT3 inhibitors. A median duration of response had not been
reached as of the ASH data cutoff on October 24, 2022.
- Recommended Phase 2 dose for ziftomenib in NPM1-mutant
AML – In December, Kura also announced that 600 mg
once-daily dosing has been designated as the recommended Phase 2
dose and schedule for ziftomenib in NPM1-mutant AML following a
positive Type C meeting with the U.S. Food and Drug Administration
(FDA). Agreement was also reached on key elements of the Company’s
Phase 2 registration-directed trial design.
- First patients dosed in registration-directed trial of
ziftomenib in NPM1-mutant AML – Earlier this month, Kura
announced that multiple patients had been dosed in its Phase 2
registration-directed trial (KOMET-001) of ziftomenib in
NPM1-mutant relapsed or refractory AML. The Company expects to
enroll a total of 85 patients in the U.S. and Europe. The primary
endpoint is CR or CR with partial hematologic recovery (CRh), and
key secondary endpoints include duration of response, transfusion
independence, safety and tolerability. 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.
- Combination trials to support commercial potential for
ziftomenib – Kura is preparing to initiate multiple Phase
1 trials to evaluate ziftomenib in combination with current
standards of care in earlier lines of therapy and across multiple
patient populations, including NPM1-mutant and KMT2A-rearranged
AML. The Company intends to establish a foundation where ziftomenib
can be combined safely with various commonly used regimens, such as
venetoclax plus azacitidine, FLT3 inhibitors and standard induction
cytarabine plus daunorubicin (7+3) chemotherapy, then prioritize
those combinations that represent the largest populations and
greatest potential commercial value. Kura expects to initiate the
first of these trials, KOMET-007, in the first half of 2023.
- Preliminary proof of mechanism of tipifarnib plus
alpelisib in HNSCC – In October, Kura reported the first
demonstration that the combination of tipifarnib and alpelisib can
induce a durable clinical response in PIK3CA-dependent head and
neck squamous cell carcinoma (HNSCC) at the EORTC-NCI-AACR
Molecular Targets and Cancer Therapeutics Symposium. A patient with
stage III squamous cell carcinoma of the tonsil with a PIK3CA
mutation achieved a durable partial response in the Company’s
KURRENT-HN trial and continued on-study for more than 27 weeks as
of the data cutoff on September 14, 2022. Treatment-related adverse
events in KURRENT-HN are consistent with the known safety profiles
of each drug and are manageable, with no dose-limiting toxicities
reported to date.
- IND for KO-2806, a next-generation farnesyl transferase
inhibitor – Last month, Kura announced FDA clearance of
its Investigational New Drug (IND) application for KO-2806 for the
treatment of advanced solid tumors. KO-2806 is a potent inhibitor
of farnesyl transferase designed to improve upon potency,
pharmacokinetic and physicochemical properties of earlier FTI drug
candidates. The Company intends to evaluate safety, tolerability
and preliminary antitumor activity of KO-2806 in a Phase 1
dose-escalation trial (FIT-001) as a monotherapy and in combination
with other targeted therapies in adult patients with advanced solid
tumors.
- $25 million equity investment from Bristol Myers
Squibb – In November, Kura sold 1,370,171 shares to
Bristol Myers Squibb at a price of $18.25 per share for gross
proceeds of $25 million. In connection with the equity investment,
Bristol Myers Squibb has appointed a member to Kura’s Global
Steering Committee. The equity investment further strengthens the
relationship between the two organizations and enables Bristol
Myers Squibb, a leader in the discovery and development of
transformational cancer treatments, to provide valuable strategic
input into Kura’s global development strategy.
Financial Results
- Research and development expenses for the fourth quarter of
2022 were $22.7 million, compared to $21.0 million for the fourth
quarter of 2021. R&D expenses for the full year 2022 were $92.8
million, compared to $84.7 million for the prior year.
- General and administrative expenses for the fourth quarter of
2022 were $12.5 million, compared to $12.1 million for the fourth
quarter of 2021. G&A expenses for the full year 2022 were $47.1
million, compared to $46.5 million for the prior year.
- Net loss for the fourth quarter of 2022 was $33.1 million,
compared to a net loss of $32.7 million for the fourth quarter of
2021. Net loss for the full year 2022 was $135.8 million, compared
to a net loss of $130.5 million for the prior year. Net loss for
the fourth quarter and full year 2022 included non-cash,
share-based compensation expense of $6.8 million and $26.3 million,
respectively, compared to $6.4 million and $23.6 million for the
same periods in 2021.
- Cash, cash equivalents and short-term investments totaled
$438.0 million as of December 31, 2022, including the $25 million
equity investment from Bristol Myers Squibb and a one-time $10
million draw from a term loan facility with Hercules Capital,
compared with $518.0 million as of December 31, 2021. Based on its
operating plan, management expects that cash, cash equivalents and
short-term investments will fund current operations into the fourth
quarter of 2025.
Forecasted Milestones
- Dose the first patients in the KOMET-007 combination trial of
ziftomenib in the first half of 2023.
- Present updated data from the KOMET-001 trial of ziftomenib in
NPM1-mutant AML at a medical meeting in mid-2023.
- Dose the first patients in the KOMET-008 combination trial of
ziftomenib in the second half of 2023.
- Determine the optimal biologically active dose in the
KURRENT-HN trial of tipifarnib in combination with alpelisib in
mid-2023.
- Dose the first patients in the FIT-001 dose-escalation trial of
KO-2806 in the third quarter of 2023.
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, February 23, 2023, to discuss
the financial results for the fourth quarter and full year 2022 and
to provide a corporate update. The live call may be accessed by
dialing (877) 407-4018 for domestic callers and (201) 689-8471 for
international callers and entering the conference ID: 13735896. 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. Ziftomenib
is currently enrolling patients in a Phase 2 registration-directed
trial (KOMET-001) in NPM1-mutant relapsed or refractory AML. Kura
is preparing to initiate multiple Phase 1 trials to evaluate
ziftomenib in combination with current standards of care in earlier
lines of therapy and across multiple patient populations, including
NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and
selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in
combination with alpelisib for patients with PIK3CA-dependent
HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in
a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in
combination with other targeted therapies in adult patients with
advanced solid tumors. For additional information, please visit
Kura’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, 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 fourth quarter
of 2025. 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 |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
22,668 |
|
|
$ |
20,956 |
|
|
$ |
92,812 |
|
|
$ |
84,721 |
|
General and administrative |
|
|
12,488 |
|
|
|
12,082 |
|
|
|
47,053 |
|
|
|
46,537 |
|
Total operating expenses |
|
|
35,156 |
|
|
|
33,038 |
|
|
|
139,865 |
|
|
|
131,258 |
|
Other income, net |
|
|
2,042 |
|
|
|
295 |
|
|
|
4,025 |
|
|
|
792 |
|
Net loss |
|
$ |
(33,114 |
) |
|
$ |
(32,743 |
) |
|
$ |
(135,840 |
) |
|
$ |
(130,466 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.49 |
) |
|
$ |
(0.49 |
) |
|
$ |
(2.03 |
) |
|
$ |
(1.97 |
) |
Weighted average number
ofshares used in computing net lossper share, basic and
diluted |
|
|
67,781 |
|
|
|
66,550 |
|
|
|
66,990 |
|
|
|
66,352 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KURA ONCOLOGY, INC. |
|
Balance Sheet Data |
|
(unaudited) |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
Cash, cash equivalents and short-term investments |
|
$ |
437,985 |
|
|
$ |
517,960 |
|
Working capital |
|
|
422,369 |
|
|
|
499,834 |
|
Total assets |
|
|
456,306 |
|
|
|
534,051 |
|
Long-term liabilities |
|
|
11,971 |
|
|
|
4,987 |
|
Accumulated deficit |
|
|
(568,808 |
) |
|
|
(432,968 |
) |
Stockholders’ equity |
|
|
420,278 |
|
|
|
506,609 |
|
Contacts
Investors: Pete De Spain Senior 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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