Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena”, “Company”), a targeted oncology company focused on developing novel cancer therapies targeting key signaling pathways, today announced financial results for the quarter ended September 30, 2021. The Company also provided an update across the organization and pipeline, including the acceptance of an IND for their TEAD inhibitor, IK-930, as they advance it towards initiation of a Phase 1 clinical trial for patients with tumors known to have high incidence of Hippo pathway genetic alterations.
In addition to the Company’s progress on IK-930, Ikena is driving several programs targeting the RAS pathway. Emerging data from discovery and translational efforts have focused the team on key nodes in the RAS pathway that provide potential for clinical advancement of targeted therapies both as single agents and in combination to overcome therapeutic resistance in RAS mutated cancers. This work includes further efforts on ERK5 biology and chemistry optimization prior to candidate nomination, but also highlights new opportunities in the pathway. Multiple development candidates are expected to emerge from these RAS discovery programs over the next 18 months.
“Patients with mutations in the Hippo and RAS pathways represent cancer populations with significant unmet needs. At Ikena, we are committed to generating deep scientific support for our approach in these pathways and in the identification of therapies that could best treat their individual disease,” commented Mark Manfredi, Ph.D., Chief Executive Officer of Ikena. “The team has done tremendous work exploring TEAD biology, advancing IK-930, and generating robust translational data to optimize the clinical development plan. The IND acceptance is a foundational milestone for our targeted oncology portfolio and for our approach to biomarker-driven cancer treatments. The progress across the entirety of our pipeline demonstrates our commitment to science and medicine that will lead to better therapies with the best chance of helping patients.”
Summary of Recent Pipeline Progress and Corporate Update
Financial Results for the Quarter Ended September 30, 2021
As of September 30, 2021, the Company had cash and cash equivalents totaling $245.9 million, which will fund operations through 2023. Net cash used in operations was $18.0 million for the third quarter of 2021 as compared to $7.7 million for the third quarter of 2020.
Research and development expenses for the third quarter 2021 were $13.4 million, compared to $7.2 million for the third quarter 2020. The increase in research and development expense was primarily attributable to IND-enabling studies, manufacturing development costs and clinical trial start-up costs for IK-930, manufacturing costs for IK-175, the on-going IND-enabling studies for IK-412, and research activities for other discovery stage programs. In addition, research and development expenses related to personnel and overhead expenses 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-007.
General and administrative expenses for the third quarter were $4.9 million, compared to $1.8 million for the third quarter 2020. 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 audit, legal, consulting and facilities expenses to support our operations as a public company.
Net loss for the third quarter 2021 was $14.5 million, compared to $6.2 million for the third quarter.
About Ikena Oncology
Ikena Oncology is focused on developing novel therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing multiple programs that target tumor markers as well as programs targeting the tumor microenvironment. The Company’s lead program, IK-930, is a TEAD inhibitor targeting the Hippo signaling pathway, a pathway that can drive formation and increase survival of tumors and also drives development of resistance to multiple existing therapies. Additional programs include those targeting the RAS signaling pathway and several programs targeting the tumor microenvironment and immune signals, two of which are being developed in collaboration with Bristol Myers Squibb. Ikena’s pipeline is built on targeting 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.comwww.ikenaoncology.com or follow us on Twitter and LinkedIn. 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, 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, including the timing of the clinical trial for IK-930; 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) | |||||||
September 30, 2021 | December 31, 2020 | ||||||
Cash and cash equivalents | $ | 245,899 | $ | 162,491 | |||
Total assets | 261,705 | 168,404 | |||||
Total liabilities | 58,442 | 63,473 | |||||
Redeemable convertible preferred stock | - | 205,979 | |||||
Additional paid-in-capital | 351,478 | 10,288 | |||||
Accumulated deficit | (148,251 | ) | (111,339 | ) | |||
Total stockholders' equity (deficit) | 203,263 | (101,048 | ) |
Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||
(Unaudited) | |||||||||||||||
(in thousands) | |||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Research and development revenue under collaboration agreement | $ | 3,746 | $ | 2,829 | $ | 10,768 | $ | 9,129 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 13,375 | 7,218 | 34,770 | 21,445 | |||||||||||
General and administrative | 4,893 | 1,844 | 12,928 | 6,150 | |||||||||||
Total operating expenses | 18,268 | 9,062 | 47,698 | 27,595 | |||||||||||
Loss from operations | (14,522 | ) | (6,233 | ) | (36,930 | ) | (18,466 | ) | |||||||
Other income | 7 | 11 | 18 | 261 | |||||||||||
Net loss and comprehensive loss | $ | (14,515 | ) | $ | (6,222 | ) | $ | (36,912 | ) | $ | (18,205 | ) | |||
Net loss per share attributable to common stockholders basic and diluted | $ | (0.40 | ) | $ | (2.34 | ) | $ | (1.46 | ) | $ | (6.85 | ) | |||
Weighted-average common stocks outstanding, basic and diluted | 35,860,284 | 2,658,800 | 25,305,212 | 2,657,793 |
Media Contact: | Investor Contact: |
Gwen Schanker | Rebecca Cohen |
LifeSci Communications | Ikena Oncology |
This email address is being protected from spambots. You need JavaScript enabled to view it. | This email address is being protected from spambots. You need JavaScript enabled to view it. |
Last Trade: | US$1.70 |
Daily Change: | 0.02 1.19 |
Daily Volume: | 16,254 |
Market Cap: | US$82.040M |
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