Ikena Oncology Inc

Previous wording

On January 17, 2024, our board of directors approved a plan to reduce our workforce by approximately 35% and discontinue discovery efforts. The workforce reduction was designed to align our workforce with our strategy to focus on our clinical stage, targeted oncology programs, IK-930 and IK-595. In connection with the workforce reduction, we terminated approximately 20 employees. We also sold laboratory equipment related to our discovery efforts. The workforce reduction and discontinuation of discovery efforts are referred to as the “January Restructuring” and were completed by March 31, 2024.

Current wording

On January 17, 2024, our board of directors approved a plan to reduce our workforce by approximately 35% and discontinue discovery efforts. The workforce reduction was designed to align our workforce with our strategy to focus on our clinical stage, targeted oncology programs, IK-930 and IK-595. In connection with the workforce reduction, we terminated 20 employees. We also sold laboratory equipment related to our discovery efforts. The workforce reduction and discontinuation of discovery efforts are referred to as the “January Restructuring” and were completed by March 31, 2024.

Previous wording

On May 28, 2024, we announced our intention to explore, review and evaluate strategic options. Based on a review of clinical data to date, available resources, and our strategic priorities, we discontinued development of IK-930, a selective inhibitor of the transcriptional enhanced associate domain 1, small molecule inhibitor of the Hippo signaling pathway. We are seeking strategic options for the program, including potential partners for development of IK-930 in combination with other targeted agents. Our board of directors also approved a workforce reduction of approximately 53% (the “May Restructuring” and together with the January Restructuring, the “Restructurings”). The May Restructuring will result in the termination of approximately 18 employees and is expected to be completed by September 30, 2024.

Current wording

On May 28, 2024, we announced our intention to explore, review and evaluate strategic options. Based on a review of clinical data to date, available resources, and our strategic priorities, we discontinued development of IK-930, a selective inhibitor of the transcriptional enhanced associate domain 1, small molecule inhibitor of the Hippo signaling pathway. We are seeking strategic options for the program, including potential partners for development of IK-930 in combination with other targeted agents. Our board of directors also approved a workforce reduction of approximately 53% (the “May Restructuring” and together with the January Restructuring, the “Restructurings”). The May Restructuring resulted in the termination of 18 employees through September 30, 2024.

Previous wording

Since inception, we have incurred significant operating losses. Our net losses were $29.9 million for the six months ended June 30, 2024 and $68.2 million for the year ended December 31, 2023. As of June 30, 2024, we had an accumulated deficit of $312.3 million. We expect to continue to incur expenses and operating losses as we:

Current wording

Since inception, we have incurred significant operating losses. Our net losses were $40.1 million for the nine months ended September 30, 2024 and $68.2 million for the year ended December 31, 2023. As of September 30, 2024, we had an accumulated deficit of $322.5 million. We expect to continue to incur expenses and operating losses as we:

Previous wording

Collaboration revenue was related to the Bristol-Myers Squibb Collaboration Agreement for the IK-175 and IK-412 programs which was executed in January 2019. The decrease in revenue during each of the three and six months ended June 30, 2024, as compared to the same periods in the prior year, was due to completion of research activities under the collaboration in 2023.

Current wording

Collaboration revenue was related to the Bristol-Myers Squibb Collaboration Agreement for the IK-175 and IK-412 programs which was executed in January 2019. The decrease in revenue during each of the three and nine months ended September 30, 2024, as compared to the same periods in the prior year, was due to completion of research activities under the collaboration in 2023.

Previous wording

Research and development expense decreased by $5.3 million from $15.2 million for the three months ended June 30, 2023 to $9.8 million for the three months ended June 30, 2024 primarily due to the prioritization of our clinical stage programs and the discontinuation of our discovery efforts. Personnel related expenses decreased by $2.8 million primarily due to reductions in our headcount. Other research and development costs decreased by $1.0 million primarily due to the discontinuation of early discovery efforts. Costs incurred in our discovery and other programs decreased by $1.2 million due to the prioritization of advancing our clinical stage programs, partially offset by stability costs incurred during the three months ended June 30, 2024 related to our acquisition of Pionyr Immunotherapeutics, Inc. (“Pionyr”) in August 2023. Costs related to IK-175 decreased as we completed the clinical trial. Costs related to IK-595 increased primarily due to increased clinical costs, partially offset by a decrease in costs for IND-enabling studies and manufacturing costs as we advanced IK-595 into the clinic.

Current wording

Research and development expense decreased by $7.8 million from $14.7 million for the three months ended September 30, 2023 to $6.8 million for the three months ended September 30, 2024 primarily due to the prioritization of our clinical stage program, IK-595, and the discontinuation of our discovery efforts. Personnel related expenses decreased by $3.2 million primarily due to reductions in our headcount. Other research and development costs decreased by $1.8 million primarily due to the discontinuation of early discovery efforts. Costs incurred in our discovery and other programs decreased by $3.1 million due to the prioritization of advancing our clinical stage program, IK-595, partially offset by stability costs related to Pionyr Immunotherapeutics, Inc. (“Pionyr”). Costs related to IK-175 decreased by $0.4 million due to completion of the clinical trial. Costs related to IK-930 decreased by $0.4 million due to completion of patient enrollment. Costs related to IK-595 increased by $1.0 million primarily due to increased clinical costs, partially offset by a decrease in costs for IND-enabling studies and manufacturing costs as we advanced IK-595 into the clinic.

Previous wording

Research and development expense decreased by $11.2 million from $30.7 million for the six months ended June 30, 2023 to $19.5 million for the six months ended June 30, 2024 primarily due to the prioritization of our clinical stage programs and the discontinuation of our discovery efforts. Personnel related expenses decreased by $4.8 million primarily due to reductions in our headcount. Other research and development costs decreased by $1.3 million due to the discontinuation of early discovery efforts. Costs incurred in our discovery and other programs decreased by $3.4 million primarily due to the prioritization of our clinical stage programs and a refund of manufacturing costs and close-out credits from the final close-out of the Pionyr clinical studies, partially offset by Pionyr stability costs. Costs related to IK-175 decreased as we completed the clinical trial. Costs related to IK-930 decreased primarily due to timing of manufacturing activities, partially offset by increased clinical trial costs due to increased patient enrollment. Costs related to IK-595 increased slightly due to an increase in clinical costs being mostly offset by a decrease in manufacturing and preclinical costs as we advanced IK-595 into the clinic.

Current wording

Research and development expense decreased by $19.1 million from $45.4 million for the nine months ended September 30, 2023 to $26.3 million for the nine months ended September 30, 2024 primarily due to the prioritization of our clinical stage programs and the discontinuation of our discovery efforts. Personnel related expenses decreased by $8.0 million primarily due to reductions in our headcount. Other research and development costs decreased by $3.1 million due to the discontinuation of early discovery efforts. Costs incurred in our discovery and other programs decreased by $6.4 million primarily due to the prioritization of our clinical stage programs and a refund of manufacturing costs and close-out credits from the final close-out of the Pionyr clinical studies, partially offset by Pionyr stability costs. Costs related to IK-175 decreased by $1.8 million due to completion of the clinical trial. Costs related to IK-930 decreased by $0.8 million primarily due to timing of manufacturing activities, partially offset by increased clinical trial costs due to increased patient enrollment. Costs related to IK-595 increased by $1.1 million due to an increase in clinical costs partially offset by a decrease in manufacturing and preclinical costs as we advanced IK-595 into the clinic.

Previous wording

The increase in general and administrative expense from the six months ended June 30, 2023 to the six months ended June 30, 2024 of $0.7 million was primarily attributable to increased costs associated with the Pionyr facility, partially offset by a decrease in personnel related costs due to reductions in our headcount and a decrease in insurance costs.

Current wording

The decrease in general and administrative expense from the three months ended September 30, 2023 to the three months ended September 30, 2024 of $1.3 million was primarily attributable to a decrease in personnel related costs due to reductions in our headcount and decreases in intellectual property-related legal costs, audit fees associated with the Pionyr acquisition and insurance costs, partially offset by increased facility costs.

Previous wording

The slight decrease in general and administrative expense from the three months ended June 30, 2023 to the three months ended June 30, 2024 was primarily attributable to a decrease in personnel related costs due to reductions to our headcount and decreases in insurance and recruiting costs being mostly offset by increased facility and legal costs associated with Pionyr.

Current wording

The decrease in general and administrative expense from the nine months ended September 30, 2023 to the nine months ended September 30, 2024 of $0.5 million was primarily attributable to a decrease in personnel related costs due to reductions in our headcount and decreases in insurance costs and intellectual property-related legal costs, partially offset by increased facility costs.

Previous wording

For the three months ended June 30, 2024, restructuring and other charges primarily included employee separation charges of $0.7 million related to the May Restructuring.

Current wording

For the three months ended September 30, 2024, restructuring and other charges primarily included employee separation charges of $0.2 million related to the May Restructuring and retention expense of $0.7 million.

Previous wording

For the six months ended June 30, 2024, restructuring and other charges primarily included employee separation costs of $2.3 million and non-cash charges for the modification of certain equity awards of $0.3 million related to the Restructurings. Restructuring and other charges also included an impairment of property and equipment held for sale of $0.7 million.

Current wording

For the nine months ended September 30, 2024, restructuring and other charges primarily included employee separation costs of $2.4 million, retention expense of $0.7 million and non-cash charges for the modification of certain equity awards of $0.3 million related to the Restructurings. Restructuring and other charges also included an impairment of property and equipment held for sale of $0.7 million.

Previous wording

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses. We have not yet commercialized any products and we do not expect to generate revenue from sales of any product candidates for several years, if ever. To date, we have financed our operations primarily through private placements of preferred stock, from upfront payments from the Bristol-Myers Squibb Collaboration Agreement, from the sale of common stock in our initial public offering (“IPO”) and underwritten registered offering of common stock (“URO”), and most recently, through the acquisition of Pionyr. As of June 30, 2024, we had cash, cash equivalents and marketable securities of $145.4 million.

Current wording

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses. We have not yet commercialized any products and we do not expect to generate revenue from sales of any product candidates for several years, if ever. To date, we have financed our operations primarily through private placements of preferred stock, from upfront payments from the Bristol-Myers Squibb Collaboration Agreement, from the sale of common stock in our initial public offering (“IPO”) and underwritten registered offering of common stock (“URO”), and most recently, through the acquisition of Pionyr. As of September 30, 2024, we had cash, cash equivalents and marketable securities of $138.0 million.

Previous wording

During the six months ended June 30, 2024, operating activities used $30.8 million of cash, primarily resulting from our net loss of $29.9 million and net cash used by changes in our operating assets and liabilities of $5.5 million, partially offset by net non-cash charges of $4.5 million, which included an impairment for assets held for sale of $0.7 million. Net cash used by changes in our operating assets and liabilities for the six months ended June 30, 2024, consisted primarily of a $6.1 million decrease in accounts payable and accrued expenses, a $1.6 million decrease in operating lease liabilities and a $0.5 million increase in prepaid expenses and other current assets, partially offset by a $2.8 million decrease in deposits and other assets.

Current wording

During the nine months ended September 30, 2024, operating activities used $39.7 million of cash, primarily resulting from our net loss of $40.1 million and net cash used by changes in our operating assets and liabilities of $5.5 million, partially offset by net non-cash charges of $5.9 million, which included an impairment for assets held for sale of $0.7 million. Net cash used by changes in our operating assets and liabilities for the nine months ended September 30, 2024, consisted primarily of a $5.3 million decrease in accounts payable and accrued expenses and a $2.3 million decrease in operating lease liabilities, partially offset by a $2.4 million decrease in deposits and other assets.

Previous wording

During the six months ended June 30, 2023, operating activities used $37.9 million of cash, primarily resulting from our net loss of $31.3 million and net cash used by changes in our operating assets and liabilities of $10.5 million, partially offset by net non-cash charges of $3.9 million. Net cash used by changes in our operating assets and liabilities for the six months ended June 30, 2023, consisted primarily of a decrease of $7.3 million in deferred revenue, a $2.3 million net decrease in accounts payable and accrued expenses, a $0.7 million decrease in operating lease liabilities and a $0.5 million increase in deposits and other assets.

Current wording

During the nine months ended September 30, 2023, operating activities used $57.9 million of cash, primarily resulting from our net loss of $48.7 million and net cash used by changes in our operating assets and liabilities of $15.3 million, partially offset by net non-cash charges of $6.0 million. Net cash used by changes in our operating assets and liabilities for the nine months ended September 30, 2023, consisted primarily of a decrease of $8.5 million in deferred revenue, a $6.3 million net decrease in accounts payable and accrued expenses, a $1.3 million decrease in operating lease liabilities and a $0.4 million increase in deposits and other assets, partially offset by a $1.3 million decrease in prepaid expenses and other current assets.

Previous wording

During the six months ended June 30, 2024, net cash used in investing activities was $44.8 million, primarily due to purchases of marketable securities of $72.3 million, partially offset by the proceeds from maturities of marketable securities of $27.2 million.

Current wording

During the nine months ended September 30, 2024, net cash used in investing activities was $35.4 million, primarily due to purchases of marketable securities of $81.0 million, partially offset by the proceeds from maturities of marketable securities of $45.2 million.

Previous wording

During the six months ended June 30, 2023, net cash provided by investing activities was $11.9 million, primarily due to proceeds from maturities of marketable securities of $59.1 million, partially offset by purchases of marketable securities of $47.1 million.

Current wording

During the nine months ended September 30, 2023, net cash provided by investing activities was $43.8 million, primarily due to proceeds from maturities of marketable securities of $109.1 million, partially offset by purchases of marketable securities of $65.2 million.

Previous wording

During the six months ended June 30, 2023, net cash provided by financing activities was $37.0 million, primarily due to proceeds from the issuance of common stock in our URO of $37.5 million, net of offering costs, partially offset by the repurchase of common stock of $0.7 million.

Current wording

During the nine months ended September 30, 2023, net cash provided by financing activities was $75.9 million, primarily due to proceeds from the issuance of common stock in our URO of $37.4 million, net of offering costs, cash and cash equivalents acquired in connection with the acquisition of Pionyr of $40.0 million, net of issuance costs partially offset by the cash consideration paid in connection with the acquisition of Pionyr of $0.9 million and the repurchase of common stock of $0.7 million.

Previous wording

As of June 30, 2024, we had cash, cash equivalents, and marketable securities of $145.4 million. We believe that our cash, cash equivalents and marketable securities as of June 30, 2024 will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months following the date of this filing. Our belief with respect to our ability to fund operations is based on estimates that are subject to risks, uncertainties and assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future operating and capital requirements will depend on many factors, including:

Current wording

As of September 30, 2024, we had cash, cash equivalents, and marketable securities of $138.0 million. We believe that our cash, cash equivalents and marketable securities as of September 30, 2024 will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months following the date of this filing. Our belief with respect to our ability to fund operations is based on estimates that are subject to risks, uncertainties and assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future operating and capital requirements will depend on many factors, including:

Previous wording

We have a non-cancelable operating lease agreement for our office, lab, and animal care facility space in our Boston, Massachusetts corporate headquarters. We expect the total future minimum lease payments from June 30, 2024 to lease expiration in May 2026 to be $3.5 million. Additionally, in connection with the acquisition of Pionyr, we acquired an operating lease agreement for office and lab space in San Francisco, California. The space had been vacant and in April 2024, we signed three agreements with third parties to sublease the space. We expect total future minimum lease payments from June 30, 2024 to lease expiration in April 2027 to be $6.4 million. We expect to receive fixed minimum payments of $2.4 million during this same period. Our total future minimum lease payments for each of the next five years and in total are included in Note 15 in our Annual Report on Form 10-K for the year ended December 31, 2023.

Current wording

We have a non-cancelable operating lease agreement for our office, lab, and animal care facility space in our Boston, Massachusetts corporate headquarters. We expect the total future minimum lease payments from September 30, 2024 to lease expiration in May 2026 to be $3.2 million. Additionally, in connection with the acquisition of Pionyr, we acquired an operating lease agreement for office and lab space in San Francisco, California. The space had been vacant and in April 2024, we signed three agreements with third parties to sublease the space. We expect total future minimum lease payments from September 30, 2024 to lease expiration in April 2027 to be $5.9 million. We expect to receive fixed minimum payments of $2.2 million during this same period. Our total future minimum lease payments for each of the next five years and in total are included in Note 15 in our Annual Report on Form 10-K for the year ended December 31, 2023.

Previous wording

Our management’s discussion and analysis of financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience, known trends and events, and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates under different assumptions or conditions. During the six months ended June 30, 2024, there were no material changes to our critical accounting policies from those described in our Annual Report on Form 10-K that was filed with the SEC on March 12, 2024.

Current wording

Our management’s discussion and analysis of financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience, known trends and events, and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates under different assumptions or conditions. During the nine months ended September 30, 2024, there were no material changes to our critical accounting policies from those described in our Annual Report on Form 10-K that was filed with the SEC on March 12, 2024.