Initial clinical data for IK-930 monotherapy dose escalation expected in the fourth quarter 2023
IK-595, best-in-class MEK-RAF complex inhibitor, investigational new drug (IND) submission planned by year end 2023
Underwritten public offering and acquisition of Pionyr add over $80M to balance sheet
BOSTON, Aug. 10, 2023 (GLOBE NEWSWIRE) — 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
- 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 Oncology
Ikena 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.
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: 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.
|Selected Balance Sheet Items:||June 30, 2023||December 31, 2022|
|Cash and cash equivalents||$||70,868||$||59,919|
|Total stockholders’ equity||$||156,700||$||146,969|
|Selected Financial Information|
|(in thousands, except share and per share data)|
|Statement of Operations Items:||Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development revenue under collaboration agreement||$||2,004||$||382||$||7,316||$||3,766|
|Research and development||15,172||15,488||30,723||29,831|
|General and administrative||5,322||5,845||10,598||11,848|
|Total operating expenses||20,494||21,333||41,321||41,679|
|Loss from operations||(18,490||)||(20,951||)||(34,005||)||(37,913||)|
|Total other income, net||1,375||460||2,671||583|
|Other comprehensive loss:|
|Unrealized gain (loss) on marketable securities||35||(626||)||(456||)||—|
|Total comprehensive loss||$||(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|