Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena”), a targeted oncology
company forging new territory in patient-directed cancer treatment,
today announced financial results for the first quarter ended March
31, 2022. The Company also shared updates across the pipeline,
including its clinical stage programs with the continued
advancement of IK-930, an oral transcriptional enhanced associate
domain (TEAD) inhibitor candidate targeting the Hippo signaling
pathway, and IK-175, an oral aryl hydrocarbon receptor (AHR)
antagonist.
“2022 is off to an exciting start for Ikena, with two important
milestones in our clinical programs: dosing the first patients in
our first-in-human IK-930 trial inhibiting TEAD and advancing the
IK-175 - nivolumab combination cohort to the next stage,” said
Sergio Santillana, MD, Chief Medical Officer of Ikena. “We are
thrilled with the execution of our programs in the clinic, thanks
to the commitment and experience of the investigators supporting
our trials, the passion of our team for addressing patients’ needs,
and the generous participation of cancer patients who joined our
clinical research programs.”
Ikena’s Chief Executive Officer, Mark Manfredi, PhD, commented:
“The progress we have made in the clinic this year has been an
important step for us; we are very much looking forward to sharing
initial clinical data from the IK-175 program in the second half of
the year. We believe that AHR inhibition with IK-175 has a
potential role for patients with urothelial carcinoma, head and
neck cancer, and ultimately for a range of patients whose treatment
may depend on AHR signaling.” He continued: “Across the company we
continue to mature, including adding key talent to the team, like
Joti, and enhancing R&D capabilities including what we gain
through our new alliance with Vall d’Hebron Institute of Oncology.
We are excited about what is to come for the rest of 2022 and
beyond as we continue Ikena’s steady growth.”
Summary of Recent Pipeline Progress and Corporate
Update
- IK-930: TEAD Inhibitor in the Hippo Signaling
Pathway
- Began dosing patients in January 2022 in the Phase 1 study of
IK-930 (NCT05228015) to evaluate safety, tolerability,
pharmacokinetics (PK), pharmacodynamics (PD), and preliminary
antitumor activity
- The FDA granted IK-930 orphan designation as a potential novel
treatment in mesothelioma in March 2022
- Shared preclinical and translational data during a presentation
at the American Association for Cancer Research 2022 Annual Meeting
in April 2022 highlighting IK-930 as a first-in-class TEAD
inhibitor to address unmet need and overcome therapeutic
resistance
- IK-175: AHR Inhibition Program Partnered with Bristol
Myers Squibb (BMS)
- In April 2022, based on emerging data on tolerability and
preliminary anti-tumor activity of IK-175 in combination with
nivolumab, Ikena advanced to Stage 2 of the expansion cohort in the
Phase 1a/1b clinical trial of IK-175 (NCT04200963) in metastatic
urothelial carcinoma patients who have progressed on prior lines of
therapy, including checkpoint inhibitors
- Ikena plans to submit the initial clinical data from this trial
to an oncology conference in the second half of 2022, and plans to
initiate a second Phase 1b trial of IK-175 in combination with
nivolumab in head and neck squamous cell carcinoma in the second
half of 2022
- Research and Development & Pipeline Growth
- Ikena and the Vall d’Hebron Institute of Oncology (VHIO)
announced a research and development partnership in early May 2022
- This partnership will enable Ikena to further deepen its
understanding of the Hippo and RAS pathways to help inform clinical
development strategies, and provide Ikena access to world-class
researchers and an extensive biobank of patient tumor samples and
novel tumor models
- Organizational Growth
- Appointment of Jotin Marango, MD, PhD, as Chief Financial
Officer and Head of Corporate Development
- Dr. Marango brings nearly 15 years of industry experience in
finance and business development and will bring together the
corporate and business development functions at Ikena
- Appointment of Richard Wooster, PhD, to Ikena’s Board of
Directors
- As an independent, research-focused director, Dr. Wooster
brings over 30 years of experience in oncology drug discovery and
development to Ikena
First Quarter 2022 Financial results
Ikena had $212.4 million in cash, cash equivalents, marketable
securities as of March 31, 2022, as compared to $232.2 million as
of December 31, 2021. Ikena believes its available cash, cash
equivalents, and marketable securities will be sufficient to meet
its operating requirements through mid-2024. Net cash used in
operating activities was $19.8 million for the quarter ended March
31, 2022, as compared to $13.2 million of cash used in operating
activities for the same period in 2021.
Research and development revenue under collaboration agreement
of $3.4 million and $3.5 million for the three months ended
March 31, 2022 and 2021, respectively, is related to the BMS
Collaboration Agreement for the IK-175 and IK-412 programs, which
was executed in January 2019.
Research and development expenses were $14.3 million for the
three months ended March 31, 2022, compared to $10.0 million
for three months ended March 31, 2021. The increase in
research and development expense was primarily attributable to
manufacturing development and clinical trial costs for IK-930 as we
began to dose patients in January 2022 in our Phase 1 study, and
research activities for other discovery stage programs. In
addition, research and development expenses related to personnel
and overhead increased due to an increase in headcount. This
increase in research and development expenses was partially offset
by a decrease in development activities for IK-412 due to the pause
of the program in Q4 2021.
General and administrative expenses were $6.0 million for the
three months ended March 31, 2022, as compared to $3.2 million
for the three months ended March 31, 2021. The increase was
primarily attributable to an increase in compensation expense due
to an increase in headcount and in insurance expense, as well as
general increases in legal, consulting and facilities expenses to
support our operations as a public company.
About Ikena OncologyIkena OncologyTM is focused
on developing novel therapies targeting key signaling pathways that
drive the formation and spread of cancer. The Company’s lead
targeted oncology program, IK-930, is a TEAD inhibitor addressing
the Hippo signaling pathway, a known tumor suppressor pathway that
also drives resistance to multiple targeted therapies. The
Company’s ongoing discovery research spans other targets in the
Hippo pathway as well as the RAS signaling pathway. Additional
programs targeting the tumor microenvironment and immune signaling
are in the clinic, including IK-175, an AHR antagonist, which is
being developed in collaboration with Bristol Myers Squibb. Ikena’s
pipeline is built on addressing genetically defined or
biomarker-driven cancers and developing therapies that can serve
specific patient populations in need of new therapeutic options. 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, statements regarding: 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; our
ability to obtain and maintain regulatory approval of our product
candidates; the implementation of our business model, 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,
and other factors discussed in the “Risk Factors” section of
Ikena’s Form 10-Q for the quarter ended March 31, 2022, 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:Gwen SchankerLifeSci
Communicationsgschanker@lifescicomms.com
|
|
Selected Financial Information |
(in thousands, except share and per share
data) |
(unaudited) |
Statement of
Operations Items: |
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Research and development revenue under collaboration agreement |
|
$ |
3,384 |
|
|
$ |
3,474 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
14,343 |
|
|
|
10,021 |
|
General and administrative |
|
|
6,003 |
|
|
|
3,173 |
|
Total operating expenses |
|
|
20,346 |
|
|
|
13,194 |
|
Loss from operations |
|
|
(16,962 |
) |
|
|
(9,720 |
) |
Interest income |
|
|
172 |
|
|
|
4 |
|
Other loss, net |
|
|
(49 |
) |
|
|
— |
|
Other income |
|
|
123 |
|
|
|
4 |
|
Net loss |
|
$ |
(16,839 |
) |
|
$ |
(9,716 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
Unrealized loss on marketable securities |
|
|
(478 |
) |
|
|
— |
|
Total comprehensive loss |
|
$ |
(478 |
) |
|
$ |
— |
|
Net loss per share: |
|
|
|
|
|
|
|
|
Net loss per share attributable
to common stockholders basic and diluted |
|
$ |
(0.47 |
) |
|
$ |
(2.52 |
) |
Weighted-average common stocks
outstanding, basic and diluted |
|
|
36,075,407 |
|
|
|
3,850,264 |
|
Selected Balance Sheet
Items: |
|
March 31, 2022 |
|
|
December 31, 2021 |
|
Cash and cash equivalents |
|
$ |
46,877 |
|
|
$ |
232,217 |
|
Marketable securities |
|
$ |
165,498 |
|
|
$ |
- |
|
Total assets |
|
$ |
227,747 |
|
|
$ |
247,879 |
|
Total liabilities |
|
$ |
34,792 |
|
|
$ |
40,002 |
|
Additional paid-in-capital |
|
$ |
355,690 |
|
|
$ |
353,295 |
|
Accumulated deficit |
|
$ |
(162,293 |
) |
|
$ |
(145,454 |
) |
Total stockholders' equity |
|
$ |
192,955 |
|
|
$ |
207,877 |
|
|
|
|
|
|
|
|
|
|
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