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Ikena Oncology Reports Second Quarter 2021 Financial Results and Provides Update on Key Programs IK-930 IND on track for submission in 2021; multiple upcoming preclinical and translational conference presentations on TEA

Key Takeaway: Ikena Oncology Reports Second Quarter 2021 Financial Results and Provides Update on Key Programs IK-930 IND on track for submission in 2021; multiple upcoming preclinical and translational conference presentations on TEAD inhibition by IK-930 Progressing IK-175 clinical trial m

Full Press Release Details

Ikena Oncology Reports Second Quarter 2021 Financial Results and Provides Update on Key Programs
IK-930 IND on track for submission in 2021; multiple upcoming preclinical and translational conference presentations on TEAD inhibition by IK-930
Progressing IK-175 clinical trial monotherapy expansion cohort in bladder cancer patients
Continued progress across targeted oncology pipeline towards research and clinical milestones
BOSTON-August 12, 2021-- Ikena Oncology, Inc. (Nasdaq: IKNA, "Ikena"), a targeted oncology company focused on developing novel cancer therapies targeting key signaling pathways, today announced financial results for the quarter that ended June 30, 2021. The Company also shared updates on several pipeline programs targeting tumor signaling pathways, including Hippo, RAS, and the tumor microenvironment.
"In recent months, the Ikena team has continued to generate data on the important targets we are exploring and our development candidates. This work has further elucidated the potential of TEAD inhibition as a monotherapy and in combination with other targeted therapies, and enables us to further refine the clinical development strategy for IK-930, our novel TEAD inhibitor," said Mark Manfredi, PhD, Chief Executive Officer of Ikena Oncology. "We look forward to sharing these and more updates as our data matures and we make strides towards our goal to transform the landscape of cancer treatment to a targeted, patient-focused treatment paradigm."
Ikena is also evaluating our novel AHR antagonist, IK-175, in a Phase I clinical trial as a monotherapy and in combination with nivolumab for the treatment of advanced or metastatic solid tumors, including in urothelial carcinoma, a type of bladder cancer where there is a significant unmet need. After completing the monotherapy dose escalation we are progressing the expansion cohort and enrolling additional urothelial carcinoma patients to continue evaluating IK-175 as a monotherapy and the path towards proof-of-concept in this patient population.
"The emerging clinical data observed for IK-175 monotherapy in urothelial carcinoma and the expansion of the cohort are great steps toward establishing proof of concept. These patients have very limited options for treatment, and we are hopeful that IK-175 could have significant impact in this setting," said Sergio Santillana, MD, Chief Medical Officer at Ikena. "The monotherapy cohort expansion is an encouraging development for the Ikena team and ultimately for the patients whose cancer could be treated with this novel therapy. We look forward to generating additional data and providing an update on safety and preliminary anti-tumor activity of IK-175 at a medical conference in 2022."
Recent Pipeline Progress and Corporate Update
Financial Results for the Quarter Ended June 30, 2021
As of June 30, 2021, the Company had cash and cash equivalents totaling $264.0 million, which will fund operations through 2023. Net cash used in operations was $15.7 million for the second quarter of 2021 as compared to $7.7 million for the second quarter of 2020.
Research and development expenses for the second quarter 2021 were $11.4 million, compared to $6.3 million for the second quarter 2020. The increase in R&D expense was primarily related to on-going IND-enabling studies and manufacturing development costs for IK-930, ongoing IND-enabling studies for IK-412, increased research activities of other discovery stage programs and increased personnel expenses due to increase in headcount. The increase in research and development expenses was offset by a decrease in expense attributable to drug manufacturing of IK-175 and a decrease in clinical activities for IK-007.
General and administrative expenses for the second quarter were $4.9 million, compared to $1.8 million for the second quarter 2020. The increase in G&A expense was primarily related to compensation expense due to an increase in headcount, as well as general increases in audit, legal and consulting expenses to support our operations as a public company.
Net loss for the second quarter 2021 was $12.7 million, compared to $5.0 million for the second quarter 2020, driven by increases in research and development and general and administrative expenses.
About Ikena Oncology
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, statements regarding: the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding the timing of the expansion of the monotherapy cohort for IK-175; the future availability of key components in the manufacture of IK-412; our expectations regarding delays in our clinical trials, including for IK-412; our expectations regarding the progression of our preclinical studies, including IND-enabling studies for IK-412; our expectations regarding the timing of presentation of preclinical and clinical data; 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 ability to demonstrate 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, and strategic plans for our business and product candidates: and other risks identified in our SEC filings, including our Registration Statement on Form S-1, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made and should not be relied on as representing our views as of any subsequent date. 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.
Condensed Consolidated Balance Sheet Data
(Unaudited)
(in thousands)
June 30, 2021 December 31, 2020
Cash and cash equivalents $ 264,004 $ 162,491
Total assets 278,827 168,404
Total liabilities 62,567 63,473
Redeemable convertible preferred stock - 205,979
Additional paid-in-capital 349,960 10,288
Accumulated deficit (133,736 ) (111,339 )
Total stockholders' equity (deficit) 216,260 (101,048 )
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands)
Three Months Ended June 30, Six Months Ended June 30,
2021 2020 2021 2020
Research and development revenue under collaboration agreement $ 3,549 $ 3,073 $ 7,023 $ 6,300
Operating expenses:
Research and development 11,374 6,334 21,396 14,226
General and administrative 4,862 1,798 8,035 4,308
Total operating expenses 16,236 8,132 29,431 18,534
Loss from operations (12,687 ) (5,059 ) (22,408 ) (12,234 )
Other income (expense), net 6 21 11 251
Net loss and comprehensive loss $ (12,681 ) $ (5,038 ) $ (22,397 ) $ (11,983 )
Net loss per share attributable to common stockholders basic and diluted $ (0.35 ) $ (1.89 ) $ (1.12 ) $ (4.51 )
Weighted-average common stocks outstanding, basic and diluted 35,853,341 2,658,800 19,940,204 2,657,283
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Last updated: Aug 12, 2021