Ikena Oncology Inc
For the period ended Mar 31, 2025. Filed May 8, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 8, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0000950170-24-122818
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-08.
0000950170-25-066411
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 120 previous paragraphs and 124 current paragraphs.
74 unchanged; 32 reworded; 18 added; 13 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 7 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (18)
Current report
After a comprehensive review of strategic alternatives, including identifying and reviewing potential candidates for a strategic transaction, on December 23, 2024, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Insight Merger Sub I (“Merger Sub I”) and Insight Merger Sub II (“Merger Sub II”), our direct, wholly owned subsidiaries, and Inmagene Biopharmaceuticals (“Inmagene”), pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub I will merge with and into Inmagene, with Inmagene surviving as our direct, wholly owned subsidiary (the “Surviving Entity,” and such transaction, the “First Merger”) and immediately after the First Merger, the Surviving Entity will merge with and into Merger Sub II with Merger Sub II surviving as our direct, wholly owned subsidiary (such transaction, the “Second Merger,” and together with the First Merger, the “Merger”). If the Merger is completed, the business of the combined company will be centered around advancing Inmagene’s lead product candidate, IMG-007, in atopic dermatitis and additional immunology and inflammatory indications.
Current report
Concurrently with the execution of the Merger Agreement, we entered into Subscription Agreements with certain accredited investors (“Subscription Agreements”), pursuant to which they have agreed to purchase, immediately following the Merger, shares of our common stock for an aggregate purchase price of approximately $75.0 million. The consummation of this transaction is conditioned upon the satisfaction or waiver of the conditions set forth in the Merger Agreement and in the Subscription Agreements. The Merger and related financing are expected to close in mid-2025.
Current report
Concurrently with the execution of the Merger Agreement, we also entered into a Loan and Security Agreement (the “Loan Agreement”) with Inmagene, pursuant to which we will lend to Inmagene up to $22.5 million, consisting of (i) an initial term loan of $7.5 million, which was funded in December 2024 and (ii) additional term loans in increments of $7.5 million, of which an additional $7.5 million was funded in April 2025, subject to certain drawdown conditions (collectively, the “Term Loan Advances”). The Term Loan Advances shall bear interest, on the outstanding daily balance thereof, at a rate equal to 6.0% per annum, and may be prepaid at any time without premium or penalty. The Term Loan Advances shall be secured by certain Inmagene assets in respect of its anti-OX40 monoclonal antibody asset, IMG-007. If the Merger Agreement is terminated, the Term Loan Advances shall mature and the Loan Agreement shall terminate on the date that is six months following the termination of the Merger Agreement. Upon consummation of the Merger, all unpaid Term Loan Advances and accrued interest shall be automatically forgiven and the Loan Agreement shall terminate.
Current report
Immediately prior to the effective time of the First Merger, we are expected to enter into the Contingent Value Rights Agreement (“CVR Agreement”) with the Rights Agent pursuant to which our pre-Merger common stockholders will receive one contingent value right (each, a “CVR”) for each outstanding share of our common stock held by such stockholder on such date. Pursuant to the CVR Agreement, each CVR holder will be entitled to receive (i) 100% of the net proceeds, if any, received by us as a result of CVR Payments made to us, such as milestone, royalty or earnout payments, received under any disposition agreements related to the CVR Assets entered into prior to the closing date of the Merger and (ii) 90% of the net proceeds, if any, received by us as a result of CVR Payments received under any disposition agreement related to the CVR Assets, including but not limited to, IK-595, entered into after the closing date of the Merger and prior to the first anniversary of the Merger closing. Such proceeds will be subject to certain permitted deductions, including for applicable tax payments, certain expenses incurred by us or our affiliates, and losses incurred or reasonably expected to be incurred by us or our affiliates due to a third-party proceeding in connection with a disposition and certain wind-down costs. The CVR Payments, if any, will become payable to the Rights Agent for subsequent distribution to the CVR holders. In the event that no such proceeds are received during the term of the CVRs, holders of the CVRs will not receive any payment pursuant to the CVR Agreement. There can be no assurance that any CVR holders will receive any CVR Payments.
Current report
Our future operations are highly dependent on the success of the Merger or another strategic alternative and there can be no assurances that the Merger or any other strategic transaction will be successfully consummated or lead to increased stockholder value. If the strategic review process is unsuccessful, our board of directors may decide to pursue a dissolution and liquidation.
Current report
We have continued to divest and explore strategic alternatives related to data, technology and other intellectual property rights related to our historical business that were not in active development and which we do not consider material. Through the date of this filing, we have sold assets and out-licensed technologies for a combination of up-front payments totaling $1.9 million and potential contingent milestone payments and future royalties.
Current report
We expect to continue to incur costs and expenditures in connection with consummating the Merger and the ongoing process of exploring strategic options for the continued development of IK-595 and certain other legacy programs. There can be no assurance, however, that we will be able to successfully consummate any particular strategic transaction, including the Merger. The process of continuing to evaluate strategic transactions and pursuing the Merger may be very costly, time-consuming and complex, and we have incurred, and may in the future incur, significant costs related to these processes, such as legal, accounting and advisory fees and expenses and other related charges.
Current report
Should we continue to progress the development of our product candidates, our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more product candidates. In addition, we will incur substantial research and developments costs and other expenditures to develop such product candidates, particularly as we:
Current report
Other Income (Expense)
Current report
Other income (expense) consists of investment income and other income (expense). Investment income consists of interest earned on invested cash balances. Other income (expense) consists of miscellaneous income (expense) unrelated to our core operations.
Current report
Income Tax (Expense) Benefit
Current report
Income tax (expense) benefit is based on our estimate of taxable income, applicable income tax rates, net research and development tax credits, net operating loss carryforwards, changes in valuation allowance estimates and deferred income taxes.
Current report
Comparison of the Three Months Ended March 31, 2025 and 2024
Current report
Other Income (Expense)
Current report
Investment income was $1.4 million and $2.1 million for the three months ended March 31, 2025 and 2024, respectively. The decrease in investment income was due to decreased yields and invested balances.
Current report
Other income (expense), net consisted primarily of other income of $0.4 million for the sale of our AHR antagonist, and sublease income of $0.4 million related to our Pionyr lease. Other income (expense), net was not significant for the three months ended March 31, 2024.
Current report
Concurrently with the execution of the Merger Agreement, we also entered into the Loan Agreement with Inmagene, pursuant to which we will lend to Inmagene up to $22.5 million, consisting of (i) an initial term loan of $7.5 million, which was funded in December 2024 and (ii) additional term loans in increments of $7.5 million, of which an additional $7.5 million was funded in April 2025, subject to certain drawdown conditions, which are collectively referred to as the Term Loan Advances. The Term Loan Advances shall bear interest, on the outstanding daily balance thereof, at a rate equal to 6.0% per annum, and may be prepaid at any time without premium or penalty. The Term Loan Advances shall be secured by certain Inmagene assets in respect of its anti-OX40 monoclonal antibody asset, IMG-007. If the Merger Agreement is terminated, the Term Loan Advances shall mature and the Loan Agreement shall terminate on the date that is six months following the termination of the Merger Agreement. Upon consummation of the Merger, all unpaid Term Loan Advances and accrued interest shall be automatically forgiven and the Loan Agreement shall terminate.
Current report
As described above, we have agreed to lend to Inmagene up to $22.5 million pursuant to the Loan Agreement, of which $7.5 million was funded in December 2024, an additional $7.5 million was funded in April 2025 and the remainder is anticipated to be funded by mid-2025.
Removed paragraphs (13)
Previous report
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 report
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 report
In June 2024, our board of directors approved up to $1.3 million of retention payments to employees, subject to remaining actively employed with us.
Previous report
Despite devoting significant efforts to identify and evaluate potential strategic options, there can be no assurance that this strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. We have not set a timetable for completion of this strategic review process, and our board of directors has not approved a definitive course of action. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stockholder value, or that we will make any cash distributions to our stockholders.
Previous report
In parallel, we are continuing clinical development of IK-595, our dual MEK-RAF inhibitor. The RAS pathway is implicated in at least half a million new cancer diagnoses each year in the United States alone. Our goal is to achieve deep and sustained responses through targeting the pathway on multiple levels and leveraging the biology of known resistance mechanisms in our therapeutic design. We nominated IK-595 as our development candidate in our RAS pathway program in November 2022. IK-595 is designed to robustly inhibit MEK-RAF by gluing MEK and the RAFs (A, B, and C) in an inactive complex, thus more completely inhibiting RAS signals than existing inhibitors. IK-595’s potential ability to complex CRAF, in particular, has been shown in preclinical models to prevent a well-recognized signaling bypass mechanism that cancer cells employ to drive therapeutic resistance to other MEK and RAF drugs in this class. In addition, trapping CRAF in an inactive complex has been shown in preclinical models to prevent the kinase independent anti-apoptotic function in RAS and RAF mutant cancers, a mechanism that cannot be addressed with first generation MEK inhibitors or pan-RAF inhibitors. We are developing IK-595 as an oral therapy, with a half-life designed to enable a pharmacokinetic profile that we believe can be potentially superior to other pathway inhibitors, with the goal of optimizing the therapeutic window for patients. We treated the first patient in the dose escalation Phase 1 study of IK-595 in December 2023. In May 2024, we reported the observation of promising early pharmacokinetics and pharmacodynamics activity, with dose dependent exposure and target modulation measured in the blood.
Previous report
To date, we have not had any products approved for sale and have not generated any revenue from product sales. As of the date of this Quarterly Report on Form 10-Q, concurrent with the ongoing development of IK-595, we are actively exploring strategic options for the Company and our development pipeline.
Previous report
Collaboration Agreement and Stock Purchase Agreement with Bristol-Myers Squibb
Previous report
In January 2019, we entered into the Bristol-Myers Squibb Collaboration Agreement with Celgene Corporation (which was acquired by Bristol-Myers Squibb in November 2019), pursuant to which Bristol-Myers Squibb could elect in its sole discretion to exclusively license rights to develop and commercialize compounds (and products and diagnostic products containing such compounds) that modulate the activity of two collaboration targets, kynurenine and AHR, excluding AHR agonists for inverse agonists, known as IK-412 and IK-175, respectively. On a program-by-program basis, through the earlier of January 2024 or the completion of a Phase 1b clinical trial for each of IK-175 and IK-412, Bristol-Myers Squibb had the exclusive option to exclusively license to develop, commercialize and manufacture the relevant product candidate worldwide. Concurrent with the execution of the Bristol-Myers Squibb Collaboration Agreement, we entered into a stock purchase agreement with Celgene Corporation (now Bristol-Myers Squibb) in November 2019 (the “Stock Purchase Agreement”), pursuant to which we issued Celgene Corporation 14,545,450 shares of Series A-1 preferred stock.
Previous report
Collaboration Revenue
Previous report
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 report
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 report
Financing Activities
Previous report
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.
Reworded paragraphs (32)
Previous wording
We are a clinical stage, targeted oncology company, focused on developing differentiated therapies for patients in need that target nodes of cancer growth, spread, and therapeutic resistance. Our approach has been to target both cancer-driving targets and mechanisms of resistance to other therapies. Our program in the RAS pathway, IK-595, is a molecular glue designed to trap MEK and RAF in an inactive complex, more completely inhibiting RAS signals than existing inhibitors. Since we commenced operations in 2016, we have advanced multiple product candidates into clinical development.
Current wording
We have historically been a clinical stage targeted oncology company focused on developing differentiated therapies for patients in need that target nodes of cancer growth, spread, and therapeutic resistance. In May 2024, after an in-depth assessment of the value proposition of our programs for both patients and company stakeholders, we announced our intention to seek strategic alternatives for the business in an effort to maximize value for shareholders. At that time, we discontinued development of IK-930, our selective Hippo pathway inhibitor. While dedicating efforts towards this corporate strategy, we allocated resources to continue the development of our RAS pathways program, IK-595. IK-595 is a molecular glue designed to trap MEK and RAF in an inactive complex to more completely inhibit RAS signals than existing inhibitors.
Previous 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:
Current wording
Since inception, we have incurred significant operating losses. Our net losses were $8.6 million for the three months ended March 31, 2025 and $49.2 million for the year ended December 31, 2024. As of March 31, 2025, we had an accumulated deficit of $340.2 million.
Previous wording
As a result, we may need additional funding to support our continuing operations and pursue our strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity instruments, debt financings, or other capital sources, which may include collaborations with other companies or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, reduce or eliminate the development and commercialization of one or more of our product candidates.
Current wording
As a result, should we continue to progress the development of our product candidates, we will need substantial additional funding to support our continuing operations and pursue our strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity instruments, debt financings, or other capital sources, which may include collaborations with other companies or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, reduce or eliminate the development and commercialization of one or more of our product candidates.
Previous wording
We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain marketing approval for our product candidates. The lengthy process of securing marketing approvals for new drugs requires the expenditure of substantial resources. Any delay or failure to obtain regulatory approvals would materially adversely affect the development efforts of our product candidates and our business overall. Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate revenue from product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
Current wording
If we continue to progress the development of our product candidates, we will not generate revenue from product sales unless and until we successfully complete clinical development and obtain marketing approval for our product candidates. The lengthy process of securing marketing approvals for new drugs requires the expenditure of substantial resources. Any delay or failure to obtain regulatory approvals would materially adversely affect the development efforts of our product candidates and our business overall. Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate revenue from product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
Previous wording
We have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the foreseeable future. All of our revenue has been derived from our collaboration agreement with Celgene Corporation (acquired by Bristol-Myers Squibb) (the “Bristol-Myers Squibb Collaboration Agreement”).
Current wording
We have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the foreseeable future. All of our revenue has been derived from the collaboration agreement that we entered into with Celgene Corporation (acquired by Bristol-Myers Squibb) (the “Bristol-Myers Squibb Collaboration Agreement”) in January 2019, which gave Bristol-Myers Squibb the option to receive a global development, manufacture and commercialization license for each of our IK-412 and IK-175 programs.
Previous wording
Bristol-Myers Squibb paid a total of $95.0 million in aggregate upfront consideration related to the Bristol-Myers Squibb Collaboration Agreement and Stock Purchase Agreement. The IK-412 and IK-175 programs were eligible for opt-in through early 2024. On January 17, 2024, Bristol-Myers Squibb notified us of its decision not to opt-in on the IK-175 program. In addition, Bristol-Myers Squibb did not provide an opt-in exercise for the IK-412 program. As a result, we have regained full global rights to the IK-175 and IK-412 programs. We will not invest further in the clinical development of IK-175 or IK-412 but will pursue strategic business development opportunities, including out-licensing.
Current wording
Bristol-Myers Squibb paid a total of $95.0 million in aggregate upfront consideration related to the Bristol-Myers Squibb Collaboration Agreement and a separate stock purchase agreement. The IK-412 and IK-175 programs were eligible for opt-in through early 2024. On January 17, 2024, Bristol-Myers Squibb notified us of its decision not to opt-in on the IK-175 program. In addition, Bristol-Myers Squibb did not provide an opt-in exercise for the IK-412 program. As a result, we regained full global rights to the IK-175 and IK-412 programs. We did not record revenue for the three months ended March 31, 2025 or 2024 as we completed our performance obligations under the Bristol-Myers Squibb Collaboration Agreement in 2023.
Previous wording
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses would increase substantially in connection with clinical development activities in the future as we progress our product candidates. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of, or obtain regulatory approval for, any of our current or future product candidates.
Current wording
Research and development activities have historically been central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses would increase substantially in connection with clinical development activities in the future if we continue to progress the development of our product candidates. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that would be necessary to complete the clinical development of, or obtain regulatory approval for, any product candidates.
Previous wording
the size and cost of any future clinical trials for existing or future product candidates in our pipeline;
Current wording
the size and cost of any future clinical trials for product candidates in our pipeline;
Previous wording
the costs associated with the development of any additional programs we identify in-house or acquire through collaborations and other arrangements and the success of such collaborations;
Current wording
the costs associated with the development of any programs we identify in-house or acquire through collaborations and other arrangements and the success of such collaborations;
Previous wording
the impact of any business interruptions to our operations, including the timing and enrollment of patients in our planned clinical trials, or to those of our manufacturers, suppliers, or other vendors resulting from pandemics or similar public health crisis; and
Current wording
the impact of any business interruptions to our operations, including the timing and enrollment of patients in our clinical trials, or to those of our manufacturers, suppliers, or other vendors resulting from pandemics or similar public health crisis; and
Previous wording
General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance, and administrative functions. General and administrative expenses also include direct and allocated facility-related costs as well as professional fees for legal, patent, consulting, investor and public relations, accounting, auditing, tax services, and insurance costs.
Current wording
General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance, and administrative functions. General and administrative expenses also include direct and allocated facility-related costs as well as professional fees for legal, patent, consulting, investor and public relations, accounting, auditing, tax services, and insurance costs. We expect our general and administrative expenses to decrease in the future due to our previous workforce reductions and reduced level of business activities. We do expect to incur significant costs, however, related to the Merger, including legal, accounting and advisory expenses and other related charges.
Previous wording
Restructuring and other charges consist of costs incurred related to the Restructurings including employee-related costs and impairment of assets held for sale.
Current wording
Restructuring and other charges consist of costs incurred related to restructuring efforts that we undertook in 2024. These costs include employee-related costs and impairment of assets held for sale. Restructuring and other charges also consist of expense related to retention plans and severance payments effected in 2025.
Previous wording
The following tables summarize our results of operations (dollars in thousands):
Current wording
The following table summarizes our results of operations (dollars in thousands):
Previous wording
The following tables summarize our research and development expenses (dollars in thousands):
Current wording
The following table summarizes our research and development expenses (dollars in thousands):
Previous 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.
Current wording
Research and development expense decreased by $5.9 million from $9.6 million for the three months ended March 31, 2024 to $3.7 million for the three months ended March 31, 2025 primarily due to the prioritization of our clinical stage program, IK-595, discontinuation of our discovery efforts and discontinuation of our clinical stage program, IK-930. Personnel related expenses decreased by $2.9 million primarily due to reductions in our headcount. Other research and development costs decreased by $1.4 million primarily due to the discontinuation of early discovery efforts. Costs related to IK-930 decreased by $2.1 million due to the wind down of the clinical trial. Discovery and other programs costs decreased by $1.0 million, as costs of $1.0 million incurred in the three months ended March 31, 2024 were fully offset in the three months ended March 31, 2024 by a refund of manufacturing costs and final net close-out credits from studies for Pionyr Immunotherapeutics, Inc. (“Pionyr”), which we acquired in 2023. These decreases were partially offset by increased costs related to IK-595 of $0.8 million primarily due to increased clinical costs.
Previous wording
The following tables summarize our general and administrative expenses (dollars in thousands):
Current wording
The following table summarizes our general and administrative expenses (dollars in thousands):
Previous 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.
Current wording
The decrease in general and administrative expense from the three months ended March 31, 2024 to the three months ended March 31, 2025 of $0.4 million was primarily attributable to a decrease in personnel related costs due to reductions in our headcount and a decrease in insurance costs, partially offset by increased facility costs and increased professional fees primarily related to the Merger.
Previous 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.
Current wording
For the three months ended March 31, 2025, restructuring and other charges included employee separation costs of $1.1 million, non-cash charges for the modification of certain equity awards of $0.2 million, and retention accruals of $0.1 million.
Previous 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.
Current wording
For the three months ended March 31, 2024, restructuring and other charges included employee separation costs of $1.6 million and non-cash charges for the modification of certain equity awards of $0.3 million. Restructuring and other charges for the three months ended March 31, 2024, 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 September 30, 2024, we had cash, cash equivalents and marketable securities of $138.0 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 March 31, 2025, we had cash, cash equivalents and marketable securities of $114.1 million.
Previous 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.
Current wording
During the three months ended March 31, 2025, operating activities used $10.6 million of cash, resulting from our net loss of $8.6 million and net cash used by changes in our operating assets and liabilities of $3.3 million, partially offset by net non-cash charges of $1.3 million. Net cash used by changes in our operating assets and liabilities for the three months ended March 31, 2025, consisted primarily of a $2.1 million decrease in accounts payable and accrued expenses and a $0.9 million decrease in operating lease liabilities.
Previous 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.
Current wording
During the three months ended March 31, 2024, operating activities used $18.3 million of cash, resulting from our net loss of $16.1 million and net cash used by changes in our operating assets and liabilities of $5.3 million, partially offset by net non-cash charges of $3.1 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 three months ended March 31, 2024, consisted primarily of a $3.9 million decrease in accounts payable and accrued expenses and a $1.0 million decrease in operating lease liabilities.
Previous 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.
Current wording
During the three months ended March 31, 2025, net cash provided by investing activities was $7.9 million, due to proceeds from maturities of marketable securities of $25.1 million, partially offset by purchases of marketable securities of $17.2 million.
Previous 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.
Current wording
During the three months ended March 31, 2024, net cash used in investing activities was $48.7 million, due to purchases of marketable securities of $62.3 million, partially offset by the proceeds from maturities of marketable securities of $13.5 million.
Previous wording
We expect to continue to incur costs associated with seeking strategic alternatives as well as expenses for the foreseeable future in connection with our continuing activities, particularly as we continue the development of IK-595. In addition, if we obtain marketing approval for IK-595 or any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. Furthermore, we expect to continue to incur costs associated with operating as a public company, including increased costs of accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance costs, and investor and public relations costs. Accordingly, we may need to obtain additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce, or eliminate our research and development or future commercialization efforts.
Current wording
We expect to continue to incur costs associated with seeking strategic alternatives as well as expenses for the foreseeable future in connection with our continuing activities. In addition, if we continue to progress the development of our product candidates and if we obtain marketing approval for IK-595 or any of our other product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. Furthermore, we expect to continue to incur costs associated with operating as a public company, including costs of accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance costs, and investor and public relations costs. Accordingly, we may need to obtain additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce, or eliminate our research and development or future commercialization efforts.
Previous 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:
Current wording
As of March 31, 2025, we had cash, cash equivalents, and marketable securities of $114.1 million. Based upon our current operating plan, we believe that, if the Merger is not consummated, our cash, cash equivalents and marketable securities as of March 31, 2025 will enable us to fund our operating expenses, notes to Inmagene 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. Because our resource requirements could change depending on the outcome of our ongoing strategic alternative review process, we are unable to estimate the exact amount of our working capital requirements. In addition to factors related to the exploration of strategic options for the continued development of IK-595 and certain other legacy programs, if the Merger is not consummated or if we continue to progress the development of our product candidates, our future operating and capital requirements may depend on many other factors, including:
Previous wording
the scope and cost to continue and execute our clinical trial for our ongoing clinical program;
Current wording
the scope and cost to continue and execute clinical trials for our clinical programs;
Previous wording
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other strategic transactions. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders’ ownership interests may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect our stockholders’ rights. Any debt financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business.
Current wording
If the Merger is not consummated, until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other strategic transactions. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders’ ownership interests may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect our stockholders’ rights. Any debt financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business.
Previous wording
On April 27, 2022, we filed a shelf registration statement on Form S-3 (“Shelf”), with the SEC, which covers the offering, issuance, and sale by us of up to an aggregate of $300.0 million of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof. We simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, to provide for the issuance and sale by us of up to $100.0 million of our common stock from time to time in “at-the-market” offerings under the Shelf, which we refer to as the “ATM Program.” The Shelf was declared effective by the SEC on May 5, 2022. As of the date hereof, no sales have been made pursuant to the ATM Program.
Current wording
On April 27, 2022, we filed a shelf registration statement on Form S-3 (“Shelf”), with the SEC, which covers the offering, issuance, and sale by us of up to an aggregate of $300.0 million of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof. We simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, to provide for the issuance and sale by us of up to $100.0 million of our common stock from time to time in “at-the-market” offerings under the Shelf, which we refer to as the ATM Program. The Shelf was declared effective by the SEC on May 5, 2022 and expired on May 5, 2025. No sales were made under the Shelf pursuant to the ATM Program.
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 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.
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 March 31, 2025 to lease expiration in May 2026 to be $2.3 million. Additionally, in connection with the acquisition of Pionyr, we acquired an operating lease agreement for office and laboratory space in San Francisco, California which we subleased to third parties in April 2024. We expect total future minimum lease payments from March 31, 2025 to lease expiration in April 2027 to be $4.8 million. We expect to receive fixed minimum payments of $1.8 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 13 in our Annual Report on Form 10-K for the year ended December 31, 2024.
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 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.
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 three months ended March 31, 2025, 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 6, 2025.
Previous wording
We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies until (1) the fiscal year following the determination that our voting and non-voting common stock held by non-affiliates is more than $250.0 million measured on the last business day of our second fiscal quarter, or (2) our annual revenues are $100.0 million or more during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is more than $700.0 million measured on the last business day of our second fiscal quarter.
Current wording
We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies until the fiscal year following the determination that our voting and non-voting common stock held by non-affiliates is more than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenues are more than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is more than $700.0 million measured on the last business day of our second fiscal quarter.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
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.