Ikena Oncology Reports First Quarter 2021 Financial Results and Outlines Key Corporate Objectives for 2021
Closed IPO and Raised
IND Submissions for Lead Targeted Oncology Program, IK-930, and BMS-partnered program, IK-412, Remain on Track for Second Half of 2021
“This first quarter marked important milestones for Ikena, both with our entrance into the public markets and the advances we have made across our pipeline. We continued to progress our clinical development programs and our lead targeted oncology program is on track for an IND submission in the second half of the year,” said
Recent Business Highlights and Corporate Update
Financial and Corporate
-
In
March 2021 , Ikena completed a successful initial public offering (IPO), raising$143.8 million in aggregate gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, and listed on The Nasdaq Global Market. The IPO followed the closing of a Series B crossover financing of$120 million in gross proceeds inDecember 2020 . -
In
April 2021 ,Maria Koehler , MD, PhD, current Chief Medical Officer ofRepare Therapeutics, Inc. (NASDAQ: RPTX), was appointed to the Ikena Board of Directors.Dr. Koehler is a board-certified hematologist and oncologist with more than 20 years of pharmaceutical and biotech oncology experience in clinical development, including senior roles at Pfizer where she contributed to the strategic direction of the oncology portfolio.
Development Pipeline
- IK-930: IND-enabling studies are ongoing for Ikena’s lead targeted oncology program, IK-930, a potent, selective and well tolerated oral small molecule TEAD inhibitor in the Hippo signaling pathway. In preclinical studies, IK-930 demonstrated anti-tumor activity in Hippo pathway-driven cancer models and synergy with EGFR inhibition and MEK inhibition.
- ERK5 Inhibitor: Lead optimization is ongoing for Ikena’s ERK5 inhibitor program which is being developed for the treatment of KRAS mutant tumors. Ikena’s ERK5 tool molecule inhibitor has shown single agent and synergistic anti-tumor activity with MEK inhibition in preclinical models of KRAS mutant pancreatic cancer and lung adenocarcinoma.
- IK-175: The ongoing Phase 1b clinical trial with IK-175, Ikena’s AHR antagonist, continues to enroll patients in the monotherapy dose expansion arm. In addition, the first patient was recently dosed in the dose escalation combination arm which consists of IK-175 with nivolumab in patients with bladder cancer, including patients with AHR-activated tumors.
- IK-412: IND-enabling studies are currently ongoing for IK-412, a novel enzymatic therapeutic designed to lower levels of kynurenine, an immunosuppressive metabolite in the tumor microenvironment. IK-412 has demonstrated profound and durable kynurenine depletion in preclinical models.
- IK-007: The ongoing Phase 1b clinical trial continues to enroll patients with advanced or progressive microsatellite stable colorectal cancer (MSS-CRC) with IK-007 in combination with pembrolizumab. The clinical trial is enriching for patients that have high urinary prostaglandin E metabolite (PGEM) biomarker.
Milestones and Key Priorities for 2021
- Complete IND-enabling studies for TEAD inhibitor, IK-930, and submit IND application to FDA during the second half of 2021.
- Nominate ERK5 inhibitor development candidate and initiate IND-enabling studies in the second half of 2021.
- Complete IND-enabling studies for kynurenine degrading enzyme, IK-412, and submit IND to FDA during the second half of 2021.
- Complete enrollment into the Phase 1b study of EP4 antagonist IK-007 in combination with pembrolizumab in patients with advanced or progressive MSS-CRC.
First Quarter 2021 Financial Results
As of
Research and development expenses for the first quarter 2021 were
General and administrative expenses for the first quarter were
Net loss for the first quarter 2021 was
About
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 our new director; 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 director; 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
Condensed Consolidated Balance Sheet Data |
||||||
(Unaudited) |
||||||
(in thousands) |
||||||
|
|
|||||
Cash and cash equivalents |
$ |
281,010 |
$ |
162,491 |
||
Total assets |
|
293,662 |
|
168,404 |
||
Total liabilities |
|
66,018 |
|
63,473 |
||
Redeemable convertible preferred stock |
|
- |
|
205,979 |
||
Additional paid-in-capital |
|
348,663 |
|
10,288 |
||
Accumulated deficit |
|
(121,055) |
|
(111,339) |
||
Total stockholders' equity (deficit) |
|
227,644 |
|
(101,048) |
Condensed Consolidated Balance Sheets |
||||||
(Unaudited) |
||||||
(in thousands) |
||||||
Three Months Ended |
||||||
2021 |
2020 |
|||||
Research and development revenue under collaboration agreement |
$ |
3,474 |
$ |
3,227 |
||
Operating expenses: |
||||||
Research and development |
|
10,021 |
|
7,893 |
||
General and administrative |
|
3,173 |
|
2,510 |
||
Total operating expenses |
|
13,194 |
|
10,403 |
||
Loss from operations |
|
(9,720) |
|
(7,176) |
||
Other income |
|
4 |
|
231 |
||
Net loss and comprehensive loss |
$ |
(9,716) |
$ |
(6,945) |
||
Net loss per share attributable to common stockholders basic and diluted |
$ |
(2.52) |
$ |
(2.62) |
||
Weighted-average common stocks outstanding, basic and diluted |
|
3,850,264 |
|
2,655,767 |
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Media Contact:
617-340-6073
liza@argotpartners.com
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646-233-4302
sam@argotpartners.com
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