Ikena Oncology Inc
For the period ended Jun 30, 2024. Filed Aug 8, 2024.
View on SEC.govAbout this filing
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.
Jun 30, 2024 · Filed Aug 8, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-13.
0000950170-24-058715
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-08.
0000950170-24-093880
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 115 previous paragraphs and 120 current paragraphs.
79 unchanged; 32 reworded; 8 added; 4 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 4 previous and 7 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 (8)
Current 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 will result in the termination of approximately 18 employees and is expected to be completed by September 30, 2024.
Current 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.
Current 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.
Current report
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 report
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 report
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 report
Financing Activities
Current report
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.
Removed paragraphs (4)
Previous report
Our most advanced targeted oncology product candidate, IK-930, is an oral, TEAD1-selective, small molecule inhibitor of the Hippo signaling pathway. The Hippo pathway is genetically altered in approximately 10% of human cancers and is widely accepted as a prevalent driver of cancer pathogenesis and a mediator of poor outcomes for patients. In our ongoing first-in-human Phase 1 clinical trial, we are focusing on indications that provide the potential to achieve rapid proof-of-concept, such as NF2 deficient mesothelioma and solid tumors with YAP1 or TAZ gene fusions, including epithelioid hemangioendothelioma (“EHE”). Approximately 40% of mesothelioma patients are genetically deficient for the tumor suppressor NF2, with approximately an additional 25-30% having partial NF2 alterations or protein loss, and 100% of EHE patients have oncogenic YAP1 or TAZ gene fusions. In October 2021, our Investigational New Drug Application (“IND”) for IK-930 was cleared by the United States Food and Drug Administration (“FDA”) and we subsequently initiated a first-in-human Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of IK-930 as a monotherapy in patients with advanced solid tumors with or without gene alterations in the Hippo pathway. IK-930 received orphan drug designation from the FDA for the treatment of mesothelioma and EHE in March 2022 and December 2023, respectively. IK-930 was granted fast track designation from the FDA for the treatment of unresectable NF2-deficient mesothelioma in June 2022. In November 2023, we shared initial dose escalation safety data and initial anti-tumor activity data from EHE patients enrolled in the dose escalation monotherapy portion of the trial. In addition to the monotherapy approach, we plan to assess IK-930 in combination with other targeted therapies across several indications with multiple targeted therapies. Based on the role that the Hippo pathway plays in resistance to other targeted therapies, we believe that IK-930 may expand the patient populations that could benefit from therapies like epidermal growth factor (“EGFR”) inhibitors, KRAS inhibitors, and MEK inhibitors, among others. We have an established clinical collaboration with AstraZeneca for the evaluation of osimertinib in combination with IK-930 for patients with EGFR-mutant lung cancers as a cohort in the clinical program. Additional data from the monotherapy IK-930 clinical program is expected in the second half of 2024.
Previous report
We expect general and administrative expenses to remain relatively flat in 2024 as compared to 2023. In the long term, we expect that our general and administrative expenses will increase as our organization grows in the future to support continued research and development activities and potential commercialization of our product candidates. These increases will likely include increased costs related to the hiring of additional personnel and fees for outside consultants, attorneys, and accountants, among other expenses. Additionally, we expect to incur increased expenses associated with being a public company, including costs of additional personnel, 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.
Previous report
the scope, progress, results and costs of discovery, preclinical development, laboratory testing, and clinical trials for other potential product candidates we may develop, if any;
Previous report
the cost of process development and technology transfer efforts to secure material for our clinical and preclinical use for our programs;
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 in the Hippo and RAS onco-signaling network. Our approach in each of our programs is to target both cancer-driving targets and mechanisms of resistance to other therapies. Our most advanced program, IK-930, is a selective inhibitor of the transcriptional enhanced associate domain 1 (“TEAD1”). The TEAD transcription factors (TEAD 1-4) execute the ultimate step in the Hippo signaling pathway, a known oncogenic pathway that also drives resistance to multiple targeted and chemo 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 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.
Previous wording
On January 17, 2024, our board of directors approved a plan to reduce our workforce by approximately 35% (the “Workforce Reduction”) and discontinue discovery efforts. The Workforce Reduction is 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. In March 2024, we committed to a plan to sell laboratory equipment related to our discovery efforts and have classified the amount as assets held for sale at their fair value less costs to sell. The Workforce Reduction and discontinuation of discovery efforts are referred to as the “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 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.
Previous wording
In addition to our work in the Hippo pathway, we have a development program targeting the RAS pathway, one of the most highly dysregulated pathways in cancer. 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.
Current wording
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 wording
To date, we have not had any products approved for sale and have not generated any revenue from product sales.
Current wording
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 wording
Since inception, we have incurred significant operating losses. Our net losses were $16.1 million for the three months ended March 31, 2024 and $68.2 million for the year ended December 31, 2023. As of March 31, 2024, we had an accumulated deficit of $298.5 million. We expect to continue to incur significant expenses and operating losses for at least the next several years as we:
Current 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:
Previous wording
initiate and continue research and preclinical and clinical development of potential new product candidates;
Current wording
initiate and continue research and clinical development of product candidates;
Previous wording
require the manufacture of larger quantities of our product candidates for clinical development and potential commercialization;
Current wording
require the manufacture of larger quantities of our product candidate for clinical development and potential commercialization;
Previous wording
As a result, 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.
Current 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.
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 will increase substantially in connection with our planned clinical development activities in the future. 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. This is due to the numerous risks and uncertainties associated with product development and commercialization, including the following:
Current 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.
Previous wording
our ability to add and retain key research and development personnel;
Current wording
our ability to attract and retain key research and development personnel as necessary;
Previous wording
our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize our product candidates;
Current wording
our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize product candidates;
Previous wording
Restructuring and other charges consist primarily of costs incurred related to the Workforce Reduction approved in January 2024 and related impairment of assets held for sale.
Current wording
Restructuring and other charges consist of costs incurred related to the Restructurings including employee-related costs and impairment of assets held for sale.
Previous wording
The following table summarizes our results of operations (dollars in thousands):
Current wording
The following tables summarize our results of operations (dollars in thousands):
Previous wording
Collaboration revenue is 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 the three months ended March 31, 2024, as compared to the same period 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 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.
Previous wording
The following table summarizes our research and development expenses (dollars in thousands):
Current wording
The following tables summarize our research and development expenses (dollars in thousands):
Previous wording
Research and development expense decreased by $5.9 million from $15.6 million for the three months ended March 31, 2023 to $9.6 million for the three months ended March 31, 2024 primarily due to the prioritization of efforts on our clinical stage programs and timing of our clinical trials. Personnel related expenses decreased by $2.0 million primarily as a result of a decrease in headcount. Costs incurred in our discovery and other programs decreased from $2.1 million in the three months ended March 31, 2023 to $1.0 million in the three months ended March 31, 2024 due to a prioritization of advancing our clinical stage programs, which costs were fully offset by a refund of manufacturing costs and final net close-out credits from studies for Pionyr Immunotherapeutics, Inc. (“Pionyr”), which we acquired in 2023, resulting in a total net decrease in discovery and other programs of $2.1 million. 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. Costs related to IK-595 decreased due to a decrease in costs for IND-enabling studies as we progressed IK-595 into the clinic. These decreases were partially offset by increased clinical trial costs for IK-930 and IK-595 due to increased patient enrollment and clinical study startup for IK-595.
Current 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.
Previous wording
The following table summarizes our general and administrative expenses (dollars in thousands):
Current wording
The following tables summarize our general and administrative expenses (dollars in thousands):
Previous wording
The increase in general and administrative expense of $0.7 million was primarily attributable to increased facility costs associated with the Pionyr facility, along with increases in legal and recruiting costs, partially offset by a decrease in insurance costs.
Current 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.
Previous wording
Restructuring and other charges consist of costs relate to the Workforce Reduction and related impairment of assets held for sale. 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 also included an impairment of property and equipment held for sale of $0.7 million.
Current 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.
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 March 31, 2024, we had cash, cash equivalents and marketable securities of $157.3 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 June 30, 2024, we had cash, cash equivalents and marketable securities of $145.4 million.
Previous wording
During the three months ended March 31, 2024, operating activities used $18.3 million of cash, primarily 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.
Current 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.
Previous wording
During the three months ended March 31, 2023, operating activities used $19.8 million of cash, primarily resulting from our net loss of $14.2 million and net cash used by changes in our operating assets and liabilities of $7.6 million, partially offset by net non-cash charges of $2.0 million. Net cash used by changes in our operating assets and liabilities for the three months ended March 31, 2023, consisted primarily of a decrease of $5.3 million in deferred revenue and a $2.3 million net decrease in accounts payable and accrued expenses.
Current 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.
Previous wording
During the three months ended March 31, 2024, net cash used in investing activities was $48.7 million, primarily due to purchases of marketable securities of $62.3 million, partially offset by the proceeds from maturities of marketable securities of $13.5 million.
Current 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.
Previous wording
During the three months ended March 31, 2023, net cash used in investing activities was $10.8 million, primarily due to purchases of marketable securities of $41.7 million, offset by the proceeds from maturities of marketable securities of $31.1 million.
Current 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.
Previous wording
We expect to continue to incur significant expenses for the foreseeable future in connection with our ongoing activities, particularly as we continue the research and development for, initiate clinical trials for, and seek marketing approval for, our product candidates. In addition, if we obtain marketing approval for 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 additional 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 will need to obtain substantial 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 programs 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, 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.
Previous wording
As of March 31, 2024, we had cash, cash equivalents, and marketable securities of $157.3 million. We believe that our cash, cash equivalents and marketable securities as of March 31, 2024 will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2026. 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 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:
Previous wording
the scope and cost to continue and execute our clinical trials for our ongoing clinical programs;
Current wording
the scope and cost to continue and execute our clinical trial for our ongoing clinical program;
Previous wording
the costs and timing of future commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;
Current wording
the costs and timing of future commercialization activities, including product sales, marketing, manufacturing and distribution, for our product candidates for which we receive marketing approval;
Previous wording
the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval;
Current wording
the amount of revenue, if any, received from commercial sales of our product candidates, should our product candidates receive marketing approval;
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, and licensing arrangements. 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
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
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, 2024 to lease expiration in May 2026 to be $4.0 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 March 31, 2024 to lease expiration in April 2027 to be $6.8 million. We expect to receive fixed minimum payments of $2.5 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 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.
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 three months ended March 31, 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 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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
This is due to the numerous risks and uncertainties associated with product development and commercialization, including the following: