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 first
quarter ended March 31, 2023. The Company also provided an update
across the organization and pipeline.
“The start to 2023 has been full of exciting developments,
including external clinical validation of the Hippo pathway and
targeting TEAD. In addition to this de-risking event, we have been
able to highlight our own differentiation in the space with
IK-930’s unique selectivity profile, optimized therapeutic index,
and broad applicability as both a monotherapy and in combination
across several patient populations. As we continue to advance in
the clinic, our ability to continuously dose patients will allow us
to fully explore IK-930’s therapeutic potential,” commented Mark
Manfredi, Ph.D., Chief Executive Officer of Ikena. “The first
quarter also was the first time we shared the novel profile of
IK-595, our MEK-RAF complex inhibitor. We designed IK-595 to
optimize the potential therapeutic window and durably bind the
RAFs, focusing on preventing multiple CRAF mechanisms that can
cause tumorigenesis. Both of these programs are aiming to serve
patient populations in which current approved and experimental
therapies are insufficient or failing. That need is driving our
entire team to continue delivering on development in the clinic,
including the IK-595 IND filing and the initial IK-930 clinical
data expected later this year.”
Summary of Recent Pipeline Progress and Corporate
Update
IK-930: TEAD1-Selective Hippo Pathway
Inhibitor
- IK-930 revealed as a TEAD1 selective
inhibitor with significant advantages in therapeutic index at
American Association for Cancer Research (AACR) Annual Meeting in
April 2023
- Multiple preclinical datasets
comparing IK-930 to panTEAD inhibition presented, including
nonhuman primate tolerability and comparable efficacy in multiple
models
- Data presented demonstrated that the
combination of IK-930 and several targeted agents, including EGFR,
KRAS G12C, and MEK inhibitors, showed a decrease in the development
of drug-resistant persister cells, suggesting the potential of
IK-930 to expand the number of patients who could benefit from
these targeted therapies
- Initial clinical data from the
monotherapy portion of the ongoing Phase 1 clinical trial of
IK-930, including patients from the dose escalation cohorts and
backfilling, is planned for the fourth quarter of 2023
- The study continues to progress as
planned through dose escalation with no reported dose-limiting
toxicities to date
- The protocol includes backfilling of
cohorts at efficacious exposures in patients with NF2-deficient
mesothelioma and epithelioid hemangioendothelioma (EHE)
- The expansion cohorts of the trial
will evaluate IK-930 as a monotherapy in these indications, as well
as in other patients with solid tumors with detectable alterations
in the Hippo pathway, including NF2 deficiency and YAP/TAZ
alterations
- Combination cohorts in the IK-930
clinical program are planned based on emerging pharmacokinetic and
pharmacodynamic data from monotherapy dose escalation; osimertinib
is the first combination partner through a clinical collaboration
with AstraZeneca
- Preclinical data exemplified the
potential of IK-930 in combination with osimertinib in EGFR mutant
cancers, both in first line as a resistance-preventative
combination and in later lines, post-resistance emergence
- Additional combinations of IK-930
with MEK inhibitors and KRAS inhibitors have the potential to
address resistance to and durability of targeted treatments in RAS
mutant cancers
IK-595: MEK-RAF Complex Inhibitor
- Data presented at the AACR Special
Conference on Targeting RAS demonstrated key differentiation
characteristics of IK-595 from first and second generation MEK
inhibitors including:
- IK-595 traps MEK and RAF in an
inactive complex to overcome CRAF bypass mechanism and block its
kinase-independent activity, more durably and completely inhibiting
RAS-MAPK signaling than existing inhibitors
- The optimization of the half-life of
IK-595 can enable dosing schedules to achieve plasma exposure above
IC90 to drive tumor cell killing, while allowing a break from
target engagement for normal tissues to recover
- Investigational new drug (IND)
application submission for IK-595 planned for the second half of
2023
- Potential indications for the
clinical program are being explored based on IK-595 sensitivity and
unmet clinical need; indication models that have shown high
sensitivity for IK-595 to date include:
- NRAS mutant cancers, including
melanoma, colorectal cancer, and acute myeloid leukemia
- KRAS mutant cancers, including
non-small cell lung, colorectal and pancreatic cancers, and
- CRAF altered cancers, which
represent an orphan population with a high unmet need and a unique
potential to benefit from IK-595’s mechanism
- Additionally, IK-595 has been shown
to be active as a monotherapy in many RAF models, including BRAF
mutant cancers, and synergistic in combination with other targeted
agents, including KRAS G12C, SHP2, SOS1, TEAD, EGFR, PI3K and mTOR
inhibitors in various RAS mutant cancer cell lines
IK-175: AHR Inhibitor in Collaboration with Bristol
Myers Squibb
- In March 2023, the FDA granted Fast
Track designation for IK-175, the Company’s novel aryl hydrocarbon
receptor (AHR) antagonist, in combination with immune checkpoint
inhibitors, in patients with advanced urothelial carcinoma who have
progressed on or within three months of receiving the last dose of
checkpoint inhibitors
- The Phase 1 clinical trial in
urothelial carcinoma has completed enrollment; treatment is ongoing
and the program is eligible for opt-in from Bristol Myers Squibb
through early 2024
Corporate Update
- Today the Company announced the
pricing of an underwritten offering for estimated gross proceeds of
approximately $40 million
- 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 March 31,
2023
As of March 31, 2023, Ikena had $137.8 million in cash, cash
equivalents and marketable securities, which does not include
proceeds from the recent underwritten offering that priced
today.
Collaboration revenue was $5.3 million and $3.4 million for the
three months ended March 31, 2023 and 2022, respectively. The
increase in collaboration revenue was primarily due to the
Company’s decision to stop the IK-175 head and neck study.
Research and development expenses were $15.6 million and $14.3
million for the three months ended March 31, 2023 and 2022,
respectively. The increase in research and development expenses of
$1.2 million was primarily related to personnel and overhead costs
due to an increase in headcount, partially offset by a decrease in
other discovery stage programs, as a result of the Company
prioritizing its focus on advancing its clinical stage
programs.
General and administrative expenses were $5.3 million and $6.0
million for the three months ended March 31, 2023 and 2022,
respectively. The decrease in general and administrative expenses
of $0.7 million 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 Statements This 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: the anticipated use of proceeds from the underwritten
offering, statements regarding the completion of the offering, 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; expectations regarding our new executive officer; 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 March 31, 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: |
|
March 31, 2023 |
|
December 31, 2022 |
Cash and cash equivalents |
|
$ |
29,329 |
|
|
$ |
59,919 |
|
Marketable securities |
|
$ |
108,484 |
|
|
$ |
97,028 |
|
Total assets |
|
$ |
152,401 |
|
|
$ |
172,259 |
|
Total liabilities |
|
$ |
17,379 |
|
|
$ |
25,290 |
|
Additional paid-in-capital |
|
$ |
363,915 |
|
|
$ |
361,915 |
|
Accumulated deficit |
|
$ |
(228,438 |
) |
|
$ |
(214,219 |
) |
Total stockholders' equity |
|
$ |
135,022 |
|
|
$ |
146,969 |
|
Selected Financial Information |
(in thousands, except share and per share
data) |
|
Statement of Operations Items: |
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
Research and development revenue under collaboration agreement |
|
$ |
5,313 |
|
|
$ |
3,384 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
15,552 |
|
|
|
14,343 |
|
General and administrative |
|
|
5,276 |
|
|
|
6,003 |
|
Total operating expenses |
|
|
20,828 |
|
|
|
20,346 |
|
Loss from operations |
|
|
(15,515 |
) |
|
|
(16,962 |
) |
Interest income |
|
|
730 |
|
|
|
172 |
|
Other income (expense) |
|
|
566 |
|
|
|
(49 |
) |
Total other income, net |
|
|
1,296 |
|
|
|
123 |
|
Net loss |
|
$ |
(14,219 |
) |
|
$ |
(16,839 |
) |
Other comprehensive loss: |
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
|
272 |
|
|
|
(478 |
) |
Total comprehensive loss |
|
$ |
(13,947 |
) |
|
$ |
(17,317 |
) |
Net loss per share: |
|
|
|
|
Net loss per share attributable to common stockholders basic and
diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.47 |
) |
Weighted-average common stocks outstanding, basic and diluted |
|
|
36,257,493 |
|
|
|
36,075,407 |
|
Ikena Oncology (NASDAQ:IKNA)
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