UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
|
|
|
|
|
|
|
|||
(State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer Identification No.) |
Ikena Oncology, Inc.
(Address of principal executive offices, including zip code)
(
(Registrant’s telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
ACTIVE/125805931.3
|
|
|
|
|
Title of each class |
|
Trade Symbol(s) |
|
Name of each exchange on which registered |
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
ACTIVE/125805931.3
Item 2.02 |
Results of Operations and Financial Condition. |
On November 9, 2023, Ikena Oncology, Inc. (the “Company”) announced its financial results for the quarter ended September 30, 2023. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information furnished pursuant to this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01 |
Other Events. |
On November 9, 2023, the Company shared initial data from twenty-six (26) patients treated in the ongoing dose escalation portion of the Phase I clinical trial of IK-930, a novel, oral, potent, and highly selective Hippo pathway inhibitor.
IK-930 Dose Escalation Summary and Differentiated Safety Profile
ACTIVE/125805931.3
Emerging Proof of Concept in EHE
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
99.1 |
|
|
104 |
|
Cover Page Interactive Data File |
ACTIVE/125805931.3
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
|
|
|
|
|
Ikena Oncology, Inc. |
||
|
|
|
|
|||
Date: November 9, 2023 |
|
|
|
By: |
|
/s/ Mark Manfredi |
|
|
|
|
|
|
Mark Manfredi, Ph.D. |
|
|
|
|
|
|
President and Chief Executive Officer |
ACTIVE/125805931.3
EXHIBIT 99.1
Ikena Oncology Shares Initial Positive and Differentiated Dose Escalation Data from IK-930 Phase I Trial and Reports Third Quarter 2023 Financial Results
Favorable safety profile in dose escalation shown to date; selective TEAD1 inhibition with IK-930 resulted in minimal treatment-related proteinuria without any dose reductions or treatment interruptions
Encouraging signs of clinical activity and tumor shrinkage in multiple patients with difficult-to-treat epithelioid hemangioendothelioma (EHE) during dose escalation
Additional IK-930 clinical data update planned for the second half of 2024; increased focus on enrollment of targeted populations including patients with mesothelioma and other NF2 mutant solid tumors
Pipeline build continues with clinical startup for IK-595, a MEK-RAF molecular glue, anticipated by end of 2023; Cash runway into 2026
BOSTON, November 9, 2023, –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 September 30, 2023, and provided a corporate update. The Company also shared initial data from twenty-six (26) patients treated in the ongoing dose escalation portion of the Phase I clinical trial of IK-930, a novel, oral, potent, and highly selective Hippo pathway inhibitor.
“This early look at the IK-930 dose escalation data strongly supports our differentiated approach to targeting the Hippo pathway. Importantly, following the target biology and initially focusing on EHE has allowed us to observe clinical activity of IK-930 early in our dose escalation. Even in the projected efficacious exposure range and at doses with clinical activity, IK-930 has thus far circumvented the renal toxicity observed with pan-TEAD inhibitors,” commented Mark Manfredi, Ph.D., Chief Executive Officer of Ikena. “Now, with IK-930’s safety profile allowing us to potentially dose patients to their optimal benefit, combined with sufficient capital to drive us through multiple data readouts, we are looking ahead to a series of rapid next steps with the program. We are increasing our focus on our targeted monotherapy indications, such as EHE and mesothelioma, and have growing confidence that as we continue the program IK-930 may be able provide the therapeutic window and clinical benefit these patient populations need.”
IK-930 Dose Escalation Summary and Emerging Proof of Concept in EHE
IK-930 selectively binds TEAD1 and broadly represses oncogenic TEAD signaling as a potent Hippo-pathway inhibitor, a known suppressor pathway in cancers such as epithelioid hemangioendothelioma (EHE), mesothelioma, meningioma, and others. IK-930’s differentiated paralog selectivity and robust repressor activity in complex with VGLL4 are key characteristics supporting anti-tumor effect in preclinical models. IK-930 is designed to circumvent renal toxicity, potentially resulting in an optimized therapeutic index. Twenty-six patients with a range of solid tumors were treated in the dose escalation portion of the study as of October 31, 2023. The most common tumor type enrolled was EHE.
Differentiated Safety Profile
Emerging Proof of Concept in EHE
Epithelioid hemangioendothelioma is a rare vascular sarcoma defined by gene fusions of either YAP or TAZ genes in the Hippo pathway with other transcriptional regulators. EHE is a slow-growing, invasive tumor with no approved treatment options and is challenging to measure due to diffuse infiltration of multiple organs. It can occur in multiple areas of the body, including the liver, lungs, bones, and blood vessels. People with EHE suffer symptoms that relentlessly affect their quality of life and are consistent with the site of the EHE growth, including liver failure, respiratory issues, and gastrointestinal symptoms, which are frequently accompanied by severe pain across the body. With no approved standard of care, there is substantial need for innovative treatments that can provide clinical benefit and symptom relief and slow or limit the progression of disease.
“EHE is a rare soft tissue sarcoma for which there is no known treatment. This tumor is 100% driven by the Hippo pathway which has motivated our initial development of IK-930 in EHE, despite the challenge of assessing the disease burden and treatment effects. The EHE patient community is one of the strongest I have worked with. The physicians, patients, and supportive community are deeply committed to finding innovative solutions in EHE, and we are immensely grateful for their partnership in these early days of the IK-930 clinical program,” commented Sergio Santillana, M.D., Chief Medical Officer of Ikena.
“The EHE community is excited by this early data from IK-930, the first targeted agent for patients with EHE, and we eagerly await more data. Rare cancers, like EHE, present significant challenges for drug developers, and we are encouraged by Ikena’s commitment to this program. We are grateful for the participation of EHE patients, caregivers, and physicians in the trial, and we look forward to continuing our partnership with Ikena,” commented Tammy Silverthorne, Executive Director of The EHE Foundation.
Summary of Additional Recent Pipeline Progress and Corporate Updates
IK-595: MEK-RAF Molecular Glue
IK-175: AHR Inhibitor in Collaboration with Bristol Myers Squibb
Corporate Updates
Financial Results for the Quarter Ended September 30, 2023
As of September 30, 2023, Ikena had $196.9 million in cash, cash equivalents and marketable securities. Net cash used in operating activities was $19.9 million for the three months ended September 30, 2023, as compared to $17.2 million of cash used in operating activities for the same period in 2022.
Collaboration revenue was $1.2 million and $6.4 million for the three months ended September 30, 2023 and 2022, respectively. The decrease in revenue of $5.2 million was primarily due to an increase in manufacturing activities as a result of the substantial completion of manufacturing efforts related to the IK-412 program during the three months ended September 30, 2022.
Research and development expenses were $14.7 million and $18.9 million for the three months ended September 30, 2023 and 2022, respectively. The decrease in research and development expenses of $4.2 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 costs incurred to wind down Pionyr clinical trials.
General and administrative expenses were $6.0 million and $5.4 million for the three months ended September 30, 2023 and 2022, respectively. The increase in general and administrative expenses of $0.6 million was primarily attributable to an increase in legal 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.
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 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; expectations with respect to projected cash runway; the anticipated use of proceeds from the Pionyr acquisition; 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; 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.
Investor Contact:
Rebecca Cohen
Ikena Oncology
rcohen@ikenaoncology.com
Media Contact:
Luke Shiplo
LifeSci Communications
lshiplo@lifescicomms.com
Financial Tables |
|
|||||||
|
|
|
|
|
|
|
||
Selected Balance Sheet Items |
|
|||||||
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
||
Cash and cash equivalents |
|
$ |
121,277 |
|
|
$ |
59,919 |
|
Marketable securities |
|
$ |
75,656 |
|
|
$ |
97,028 |
|
Total assets |
|
$ |
215,335 |
|
|
$ |
172,259 |
|
Total liabilities |
|
$ |
28,146 |
|
|
$ |
25,290 |
|
Convertible Preferred Stock |
|
$ |
31,845 |
|
|
$ |
- |
|
Additional paid-in-capital |
|
$ |
418,486 |
|
|
$ |
361,915 |
|
Accumulated deficit |
|
$ |
(262,896 |
) |
|
$ |
(214,219 |
) |
Total stockholders' equity |
|
$ |
155,344 |
|
|
$ |
146,969 |
|
Consolidated Statement of Operations and Comprehensive Loss |
|
|||||||||||||||
(in thousands, except share and per share data) |
|
|||||||||||||||
|
|
|||||||||||||||
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
Research and development revenue under collaboration agreement |
|
$ |
1,185 |
|
|
$ |
6,402 |
|
|
$ |
8,501 |
|
|
$ |
10,168 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
14,654 |
|
|
|
18,850 |
|
|
|
45,378 |
|
|
|
48,682 |
|
General and administrative |
|
|
6,034 |
|
|
|
5,428 |
|
|
|
16,632 |
|
|
|
17,276 |
|
Total operating expenses |
|
|
20,688 |
|
|
|
24,278 |
|
|
|
62,010 |
|
|
|
65,958 |
|
Loss from operations |
|
|
(19,503 |
) |
|
|
(17,876 |
) |
|
|
(53,509 |
) |
|
|
(55,790 |
) |
Investment income |
|
|
2,162 |
|
|
|
550 |
|
|
|
4,840 |
|
|
|
1,135 |
|
Other expense |
|
|
(2 |
) |
|
|
(12 |
) |
|
|
(8 |
) |
|
|
(13 |
) |
Total other income, net |
|
|
2,160 |
|
|
|
538 |
|
|
|
4,832 |
|
|
|
1,122 |
|
Net loss |
|
$ |
(17,343 |
) |
|
$ |
(17,338 |
) |
|
$ |
(48,677 |
) |
|
$ |
(54,668 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain (loss) on marketable securities |
|
|
166 |
|
|
|
(77 |
) |
|
|
(290 |
) |
|
|
(1,181 |
) |
Total comprehensive loss |
|
$ |
(17,177 |
) |
|
$ |
(17,415 |
) |
|
$ |
(48,967 |
) |
|
$ |
(55,849 |
) |
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share attributable to common stockholders basic and diluted |
|
$ |
(0.40 |
) |
|
$ |
(0.48 |
) |
|
$ |
(1.23 |
) |
|
$ |
(1.51 |
) |
Weighted-average common stocks outstanding, basic and diluted |
|
|
43,437,844 |
|
|
|
36,257,074 |
|
|
|
39,688,984 |
|
|
|
36,165,143 |
|