Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena,” “Company”), a targeted
oncology company forging new territory in patient-directed cancer
treatment, today announced financial results for the quarter ended
June 30, 2023. The Company also provided pipeline and corporate
updates from the quarter and recent months.
“It has been a busy time at Ikena, with new high-quality
investors and peers sharing our confidence in our targeted oncology
pipeline translating to important corporate milestones. We are in a
strong financial position and remain on track to deliver on our
development milestones for both IK-930 and IK-595 this year, and to
fund additional and potentially broader data events as we go deeper
into the programs,” said Mark Manfredi, PhD, Chief Executive
Officer of Ikena. “The important progress we made in the second
quarter has continued to set the programs and company up for
success, especially the presentation of our differentiated,
selective design of IK-930 and the clinical target validation of
the Hippo pathway. We are looking forward to sharing more later
this year, including the initial clinical data from IK-930, and
updates on the IND submission and clinical plan for IK-595, all of
which we see as further solidifying Ikena as a leader in the
targeted oncology space and driving value for patients and
shareholders.”
Summary of Recent Pipeline Progress and Corporate
Update
IK-930: TEAD1-Selective Hippo Pathway
Inhibitor
- IK-930’s differentiation was showcased at the American
Association for Cancer Research (AACR) Annual Meeting in April 2023
- The therapeutic index advantages of IK-930’s TEAD1 selectivity
was highlighted, including preclinical datasets comparing IK-930 to
panTEAD inhibition,
- The combination of IK-930 with targeted agents (EGFR, KRAS
G12C, MEK inhibitors) reduced drug-resistant persister cells,
potentially broadening the benefits of targeted therapies
- The ongoing Phase 1 study is progressing as planned and has
advanced through multiple dose escalation cohorts, which will be
included in the initial clinical data update planned for the fourth
quarter of 2023
IK-595: MEK-RAF Complex Inhibitor
- IND application submission for IK-595 planned by year end
2023
- Additional preclinical updates and indication selection data
for IK-595 will be presented in 2023 at the 5th Annual RAS-Targeted
Drug Discovery Development Conference in September and
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics in October
IK-175: AHR Inhibitor in Collaboration with Bristol
Myers Squibb
- The Phase 1 clinical trial in urothelial carcinoma has
completed enrollment and the program is eligible for opt-in from
Bristol Myers Squibb through early 2024
Corporate Update
- Completion of underwritten registered offering in May 2023 for
gross proceeds of approximately $40 million
- Acquisition of Pionyr Immunotherapeutics Inc. in August 2023
resulted in approximately $43 million in net cash added to the
Ikena balance sheet
- Together with its existing cash,
cash equivalents, and investments, the Company believes that cash
at hand will be sufficient to meet its operating requirements into
2026 and will fund additional data events for both IK-930 and
IK-595 beyond the initial read outs
Financial Results for the Quarter Ended June 30,
2023
As of June 30, 2023, Ikena had $157.3 million in cash, cash
equivalents and marketable securities, which does not include
proceeds from the recent acquisition of Pionyr Immunotherapeutics
Inc., which resulted in approximately $43 million in net cash added
to the balance sheet subsequent to the quarter end June 30, 2023.
Net cash used in operating activities was $18.1 million for the
three months ended June 30, 2023, as compared to $19.5 million of
cash used in operating activities for the same period in 2022.
Collaboration revenue was $2.0 million and $0.4 million for the
three months ended June 30, 2023 and 2022, respectively. The
increase in revenue was primarily due to a change in estimate made
during the period ended June 30, 2022 of the development services
expected to be performed during the term of the Bristol-Myers
Squibb Collaboration Agreement related to IK-175.
Research and development expenses were $15.2 million and $15.5
million for the three months ended June 30, 2023 and 2022,
respectively. The decrease in research and development expenses of
$0.3 million was primarily due to decreases in clinical trial costs
related to IK-175 and decreases in other discovery stage programs
as a result of the Company prioritizing its focus on advancing its
clinical stage programs, partially offset by an increase in IK-930
clinical trial costs and consulting fees.
General and administrative expenses were $5.3 million and $5.8
million for the three months ended June 30, 2023 and 2022,
respectively. The decrease in general and administrative expenses
was primarily attributable to a decrease in legal, consulting, and
insurance expenses.
About Ikena OncologyIkena Oncology® is focused
on developing differentiated therapies for patients in need that
target nodes of cancer growth, spread, and therapeutic resistance
in the Hippo and RAS onco-signaling network. The Company’s lead
targeted oncology program, IK-930, is a TEAD1 selective Hippo
pathway inhibitor, a known tumor suppressor pathway that also
drives resistance to multiple targeted therapies. The Company’s
additional research spans other targets in the Hippo pathway as
well as the RAS signaling pathway, including developing IK-595, a
novel MEK-RAF inhibitor. Additionally, IK-175, an AHR antagonist,
is being developed in collaboration with Bristol Myers Squibb.
Ikena aims to utilize their depth of institutional knowledge and
breadth of tools to efficiently develop the right drug using the
right modality for the right patient. To learn more, visit
www.ikenaoncology.com or follow us on Twitter and LinkedIn.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended,
including, without limitation, implied and express statements
regarding: projected cash runway; the anticipated use of proceeds
from the underwritten registered offering and Pionyr acquisition,
the timing and advancement of our targeted oncology programs,
including the timing of updates; our expectations regarding the
therapeutic benefit of our targeted oncology programs; our ability
to efficiently discover and develop product candidates; our ability
to obtain and maintain regulatory approval of our product
candidates; the implementation of our business model, expectations
with respect to cash runway, and strategic plans for our business
and product candidates. The words “may,” “will,” “could,” “would,”
“should,” “expect,” “plan,” “anticipate,” “intend,” “believe,”
“estimate,” “predict,” “project,” “potential,” “continue,” “target”
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Any forward-looking statements in this
press release are based on management’s current expectations and
beliefs and are subject to a number of risks, uncertainties and
important factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, those risks and uncertainties related to the timing and
advancement of our targeted oncology programs; our expectations
regarding the therapeutic benefit of our targeted oncology
programs; our ability to efficiently discover and develop product
candidates; the implementation of our business model, and strategic
plans for our business and product candidates, the sufficiency of
the Company’s capital resources to fund operating expenses and
capital expenditure requirements and the period in which such
resources are expected to be available, and other factors discussed
in the “Risk Factors” section of Ikena’s Quarterly Report on Form
10-Q for the quarter ended June 30, 2023, which is on file with the
SEC, as updated by any subsequent SEC filings. We caution you not
to place undue reliance on any forward-looking statements, which
speak only as of the date they are made. We disclaim any obligation
to publicly update or revise any such statements to reflect any
change in expectations or in events, conditions or circumstances on
which any such statements may be based, or that may affect the
likelihood that actual results will differ from those set forth in
the forward-looking statements. Any forward-looking statements
contained in this press release represent our views only as of the
date hereof and should not be relied upon as representing its views
as of any subsequent date. We explicitly disclaim any obligation to
update any forward-looking statements.
Investor Contact:Rebecca CohenIkena
Oncologyrcohen@ikenaoncology.com
Media Contact:Luke ShiploLifeSci
Communicationslshiplo@lifescicomms.com
Selected Balance Sheet Items: |
|
June 30, 2023 |
|
December 31, 2022 |
Cash and cash equivalents |
|
$ |
70,868 |
|
|
$ |
59,919 |
|
Marketable
securities |
|
$ |
86,444 |
|
|
$ |
97,028 |
|
Total
assets |
|
$ |
171,764 |
|
|
$ |
172,259 |
|
Total
liabilities |
|
$ |
15,064 |
|
|
$ |
25,290 |
|
Additional
paid-in-capital |
|
$ |
402,667 |
|
|
$ |
361,915 |
|
Accumulated
deficit |
|
$ |
(245,553 |
) |
|
$ |
(214,219 |
) |
Total
stockholders' equity |
|
$ |
156,700 |
|
|
$ |
146,969 |
|
Selected
Financial Information |
|
(in
thousands, except share and per share data) |
|
|
|
Statement of Operations Items: |
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Research and
development revenue under collaboration agreement |
|
$ |
2,004 |
|
|
$ |
382 |
|
|
$ |
7,316 |
|
|
$ |
3,766 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
15,172 |
|
|
|
15,488 |
|
|
|
30,723 |
|
|
|
29,831 |
|
|
General and
administrative |
|
|
5,322 |
|
|
|
5,845 |
|
|
|
10,598 |
|
|
|
11,848 |
|
|
Total
operating expenses |
|
|
20,494 |
|
|
|
21,333 |
|
|
|
41,321 |
|
|
|
41,679 |
|
|
Loss from
operations |
|
|
(18,490 |
) |
|
|
(20,951 |
) |
|
|
(34,005 |
) |
|
|
(37,913 |
) |
|
Investment
income |
|
|
1,381 |
|
|
|
460 |
|
|
|
2,677 |
|
|
|
583 |
|
|
Other
expense |
|
|
(6 |
) |
|
|
— |
|
|
|
(6 |
) |
|
|
— |
|
|
Total other
income, net |
|
|
1,375 |
|
|
|
460 |
|
|
|
2,671 |
|
|
|
583 |
|
|
Net
loss |
|
$ |
(17,115 |
) |
|
$ |
(20,491 |
) |
|
$ |
(31,334 |
) |
|
$ |
(37,330 |
) |
|
Other
comprehensive loss: |
|
|
|
|
|
|
|
|
|
Unrealized
gain (loss) on marketable securities |
|
|
35 |
|
|
|
(626 |
) |
|
|
(456 |
) |
|
|
— |
|
|
Total
comprehensive loss |
|
$ |
(17,080 |
) |
|
$ |
(21,117 |
) |
|
$ |
(31,790 |
) |
|
$ |
(37,330 |
) |
|
Net loss per
share: |
|
|
|
|
|
|
|
|
|
Net loss per
share attributable to common stockholders basic and diluted |
|
$ |
(0.44 |
) |
|
$ |
(0.57 |
) |
|
$ |
(0.83 |
) |
|
$ |
(1.03 |
) |
|
Weighted-average common stocks outstanding, basic and diluted |
|
|
39,292,710 |
|
|
|
36,160,951 |
|
|
|
37,783,486 |
|
|
|
36,118,415 |
|
|
|
|
|
|
|
|
|
|
|
|
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