Sensei Biotherapeutics Inc
For the period ended Sep 30, 2024. Filed Nov 14, 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.
Sep 30, 2024 · Filed Nov 14, 2024
FTH$22.05+10.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-06.
0000950170-24-091895
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-14.
0000950170-24-126748
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 133 previous paragraphs and 126 current paragraphs.
99 unchanged; 22 reworded; 5 added; 12 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 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 (5)
Current report
We currently have one investigational product candidate, SNS-101, in clinical development.
Current report
To further our objective of generating clinical data that informs both the optimal dose and patient population for Phase 2 studies, including comprehensive data from patients with both primary and acquired resistance to PD-1 inhibitors, we expect to report clinical data across two dose levels in multiple tumor types in the first half of 2025.
Current report
In October 2024, we received preliminary guidance from the FDA on the dose optimization strategy for SNS-101. We plan to reengage with the agency following completion of the dose expansion portion of the Phase 1 clinical trial.
Current report
In November 2024, we announced a plan to decrease operating expenses, streamline operations and focus resources on advancing the clinical development of SNS-101. As a result, we will close our research site in Rockville, Maryland, reduce our workforce by approximately 46%, with most headcount reductions affecting our preclinical research and development group, and pause further development of our preclinical product candidates, including SNS-102, SNS-103 and SNS-201. With this realignment of resources, we expect our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2026. We plan to continue reviewing our financial resources with the expectation that work on our preclinical product candidates will resume if we raise sufficient additional capital.
Current report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Removed paragraphs (12)
Previous report
We currently have four investigational product candidates in various stages of early development:
Previous report
As of the April 30, 2024 data cutoff:
Previous report
SNS-101 was well tolerated alone and in combination with cemiplimab, with no dose-limiting toxicities observed. The majority of AEs were Grade 1 or 2 in severity. Two patients experienced Grade 1 cytokine release syndrome (CRS), one in monotherapy and one in combination, both at the highest dose of SNS-101. Both cases were mild and manageable, demonstrating that SNS-101 has the potential to overcome a key hurdle that hindered first-generation VISTA-targeting approaches. Four patients in the combination cohort experienced immune-mediated events. There were also no significant changes to key inflammatory cytokine levels, including interferon gamma, interleukin-6, interleukin-10, interleukin-8, TNF-alpha, and CCL5-RANTES, across cohorts.
Previous report
SNS-101 demonstrated a potentially best-in-class pharmacokinetic (PK) profile with linear elimination kinetics and dose-proportional increases in exposure, supporting once every three week dosing.
Previous report
One microsatellite stable (MSS) endometrial cancer patient that received SNS-101 plus cemiplimab had a confirmed partial response (59% decrease) and as of April 30, 2024 remained on study at 30+ weeks; one MSS colorectal cancer patient that received SNS-101 plus cemiplimab remained on study for 18 weeks and had tumor regression of 27%; one pembrolizumab-resistant renal cell carcinoma patient that received SNS-101 plus cemiplimab remained on study for 12 weeks and had tumor regression of 18%; and one pembrolizumab-resistant human papillomavirus (HPV)+ head and neck cancer patient that received SNS-101 as monotherapy remained on study for 12 weeks and had tumor regression of 17%.
Previous report
We expect to report initial data from the dose expansion cohorts and hold an end-of-Phase 1 meeting with the FDA by the end of 2024.
Previous report
SNS-102 is our conditionally active monoclonal antibody targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4), an immune checkpoint often expressed on macrophages. We have selected a product candidate that is 585-fold more selective for VSIG4 at low pH conditions. Various potential counter-receptors have been provisionally identified and are currently in the process of being refined and confirmed.
Previous report
SNS-103 is our conditionally active monoclonal antibody targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1), also known as CD39. In 2023, we selected a product candidate from a set of lead-optimized antibodies.
Previous report
SNS-201 is a bispecific antibody that is being designed to conditionally activate Cluster of Differentiation 28 (CD28). It is a bispecific format with monovalent CD28 engagement and bivalent pH-selective VISTA binding for efficient engagement at low pH. In 2023, we selected a product candidate from a set of lead-optimized bispecific antibodies.
Previous report
In January 2024, we announced the expansion of the Phase 1/2 clinical trial of SNS-101 to include additional patients in a more focused set of indications. Prior to initiating the Phase 2 portion, we now plan to enroll up to an aggregate of 50 to 70 additional patients across both the monotherapy and combination arms to further optimize the Phase 2 trial design. In connection with the expansion of the Phase 1/2 trial of SNS-101, we paused the IND-enabling studies originally planned for our next TMAb product candidate. With this realignment of resources, we expect our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. Preclinical work on our TMAb product candidates to characterize selected lead antibodies, including their mechanisms of action, and target biology is expected to continue throughout 2024. We plan to continue reviewing our financial resources with the expectation that IND-enabling studies for additional TMAb product candidates will resume if we raise sufficient additional capital.
Previous report
continue the research and development of our other product candidates and prepare to submit INDs for such candidates;
Previous report
Comparison of the Six Months Ended June 30, 2024 and 2023
Reworded paragraphs (22)
Previous wording
We are an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients. Through our TMAb™ (Tumor Microenvironment Activated Biologics) platform, we are developing highly selective therapeutics designed to disable immunosuppressive signals or activate immunostimulatory signals selectively in the tumor microenvironment. Our strategy is to generate novel product candidates that incorporate next-generation technologies or approaches using our robust set of R&D capabilities. We plan to efficiently develop these product candidates by incorporating state-of-the-art biomarker approaches and mechanistic understanding into clinical trial designs targeted to well-defined patient populations.
Current wording
We are a clinical-stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients. Through our TMAb™ (Tumor Microenvironment Activated Biologics) platform, we are developing highly selective therapeutics designed to disable immunosuppressive signals or activate immunostimulatory signals selectively in the tumor microenvironment. Our strategy is to generate novel product candidates that incorporate next-generation technologies or approaches using our robust set of R&D capabilities. We plan to efficiently develop these product candidates by incorporating state-of-the-art biomarker approaches and mechanistic understanding into clinical trial designs targeted to well-defined patient populations.
Previous wording
In May 2024, we presented clinical data from the dose escalation portion of the trial at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Data were presented from a total of 34 patients who received SNS-101 once every 3 weeks, with 16 patients in the monotherapy arm and 18 patients in the combination arm. The majority of patients (85%) had a tumor type that is typically unresponsive to PD-1 monotherapy.
Current wording
In May 2024, we presented clinical data from the dose escalation portion of the trial at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Data were presented from a total of 34 patients who received SNS-101 once every 3 weeks, with 16 patients in the monotherapy arm and 18 patients in the combination arm.
Previous wording
Patient enrollment is advancing in the dose expansion portion of the Phase 1/2 study, which is now expected to enroll an aggregate of 50 to 70 patients. In the combination arm, in addition to dosing patients with 15mg/kg of SNS-101 we plan to dose patients with 3mg/kg of SNS-101 to further optimize the Phase 2 study design.
Current wording
Patient enrollment is advancing in the dose expansion portion of the Phase 1/2 study, which is now expected to enroll an aggregate of 50 to 70 patients. In the combination arm, in addition to dosing patients with 15mg/kg of SNS-101 we have begun dosing patients with 3mg/kg of SNS-101 to further optimize the Phase 2 study design.
Previous wording
We have incurred significant operating losses over the last several years. Our net loss was $15.1 million and $19.6 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $247.0 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:
Current wording
We have incurred significant operating losses over the last several years. Our net loss was $22.4 million and $26.7 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $254.3 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:
Previous wording
Our direct external research and development expenses consist primarily of external costs, such as fees paid to CROs, CMOs, research/testing laboratories and outside consultants in connection with our preclinical development, process development, manufacturing and clinical development activities. We do not allocate these costs to specific product candidates because many of them are deployed across several of our development programs and, as such, are not separately classified. We use internal resources primarily to conduct research and manage our preclinical development, process development, manufacturing and clinical development activities. These employees work across multiple development programs and, therefore, we do not track their costs by program and, as such, are not separately classified. Research and development activities are 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 our research and development expenses to increase significantly over the next several years as we increase personnel costs, including stock-based compensation, conduct our preclinical studies and clinical trials, and prepare regulatory filings for our product candidates.
Current wording
Our direct external research and development expenses consist primarily of external costs, such as fees paid to CROs, CMOs, research/testing laboratories and outside consultants in connection with our preclinical development, process development, manufacturing and clinical development activities. We do not allocate these costs to specific product candidates because many of them are deployed across several of our development programs and, as such, are not separately classified. We use internal resources primarily to conduct research and manage our preclinical development, process development, manufacturing and clinical development activities. These employees work across multiple development programs and, therefore, we do not track their costs by program and, as such, are not separately classified. Research and development activities are 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 our research and development expenses to increase significantly over the next several years as we increase personnel costs, including stock-based compensation, conduct our preclinical studies or clinical trials, and prepare regulatory filings for our product candidates.
Previous wording
Our other income (expense) consists of realized gain or loss on short-term investments, gain on debt extinguishments, accretion expense on short-term investments and interest expense.
Current wording
Our other income (expense) consists of accretion expense on short-term investments, interest expense and gain or loss on fixed asset disposals,
Previous wording
Research and development expenses were $4.6 million for the three months ended June 30, 2024, compared to $4.8 million for the three months ended June 30, 2023. The decrease of $0.2 million was primarily attributable to $0.7 million of decreased outside research fees, $0.3 million of lower costs for preclinical research, $0.2 million of less consulting fees and $0.1 million of lower facilities expense, partially offset by $0.9 million higher expense associated with clinical trials and $0.2 million of higher personnel costs, including stock-based compensation and incentives.
Current wording
Research and development expenses were $4.6 million for the three months ended September 30, 2024, compared to $3.8 million for the three months ended September 30, 2023. The increase of $0.8 million was primarily attributable to $0.9 million higher expense associated with clinical trials, $0.3 million of higher personnel costs, including stock-based compensation and incentives, and $0.1 million of higher manufacturing related expense, partially offset by $0.3 million lower costs for preclinical research and $0.2 million of lower consulting fees.
Previous wording
General and administrative expenses were $3.2 million for the three months ended June 30, 2024, compared to $5.4 million for the three months ended June 30, 2023. The decrease of $2.2 million was primarily attributable to $1.6 million of lower external professional services associated with stockholder activism related to our 2023 annual meeting of stockholders, $0.4 million of lower personnel costs, including stock-based compensation and incentives and $0.2 million less expense for directors and officers insurance.
Current wording
General and administrative expenses were $3.2 million for the three months ended September 30, 2024, compared to $3.9 million for the three months ended September 30, 2023. The decrease of $0.7 million was primarily attributable to $0.2 million less expense for directors and officers insurance, $0.2 million of lower expense for outside services, $0.2 million of lower personnel costs, including recruitment fees, stock-based compensation and incentives, and $0.1 million less license fees.
Previous wording
Other income was $0.6 million for the three months ended June 30, 2024, compared to other income of $0.8 million for the three months ended June 30, 2023. The other income decrease of $0.1 million was primarily related to a $0.2 million decrease in interest income offset by a $0.1 million related to a loss on disposals of equipment in 2023.
Current wording
Other income was $0.6 million for the three months ended September 30, 2024, compared to other income of $0.6 million for the three months ended September 30, 2023. Other income remained consistent year over year with a minor decrease primarily related to interest income.
Previous wording
The following sets forth our results of operations for the six months ended June 30, 2024 and 2023:
Current wording
The following sets forth our results of operations for the nine months ended September 30, 2024 and 2023:
Previous wording
Research and development expenses were $9.5 million for the six months ended June 30, 2024, compared to $10.0 million for the six months ended June 30, 2023. The decrease of $0.5 million was primarily attributable to $0.8 million of lower costs for preclinical research, $0.6 million lower manufacturing related expense, $0.5 million of less consulting fees, $0.4 million of lower facilities expense, $0.1 million of lower outside research fees, $0.1 million of less licensing fees and $0.1 million of lower restructuring costs, primarily offset by $1.7 million of higher expense associated with clinical trials, $0.3 million of higher personnel costs, including stock-based compensation and incentives, and $0.1 million higher expense relating to lab supply purchases.
Current wording
Research and development expenses were $14.1 million for the nine months ended September 30, 2024, compared to $13.8 million for the nine months ended September 30, 2023. The increase of $0.3 million was primarily attributable to $2.6 million of higher expense associated with clinical trials, $0.5 million of higher personnel costs, including stock-based compensation and incentives, and $0.1 million higher expense relating to lab supply purchases, primarily offset by $1.0 million of lower costs for preclinical research, $0.7 million of less consulting fees, $0.5 million lower manufacturing related expense, $0.4 million of lower facilities expense, $0.1 million of lower outside research fees, $0.1 million of less licensing fees and $0.1 million of lower restructuring costs.
Previous wording
General and administrative expenses were $7.0 million for the six months ended June 30, 2024, compared to $11.2 million for the six months ended June 30, 2023. The decrease of $4.2 million was primarily attributable to $3.0 million of lower external professional services associated with stockholder activism related to our 2023 annual meeting of stockholders, $0.6 million of lower personnel costs, including stock-based compensation and incentive, $0.4 million less expense for directors and officers insurance, $0.2 million of lower consulting costs, $0.1 million lower restructuring costs and $0.1 million of lower expense for outside services, partially offset by $0.2 million of higher facilities expense.
Current wording
General and administrative expenses were $10.2 million for the nine months ended September 30, 2024, compared to $15.1 million for the nine months ended September 30, 2023. The decrease of $4.9 million was primarily attributable to $3.0 million of lower external professional services associated with stockholder activism related to our 2023 annual meeting of stockholders, $0.8 million of lower personnel costs, including recruitment fees, stock-based compensation and incentive, $0.7 million less expense for directors and officers insurance, $0.3 million of lower expense for outside services, $0.2 million of lower consulting costs, $0.1 million of lower audit fees and $0.1 million lower restructuring costs, partially offset by $0.3 million of higher facilities expense.
Previous wording
Other income was $1.4 million for the six months ended June 30, 2024, compared to other income of $1.6 million for the six months ended June 30, 2023. The other income decrease of $0.2 million was primarily related to a $0.4 million decrease in interest income offset by a $0.2 million increase related to disposals of equipment.
Current wording
Other income was $2.0 million for the nine months ended September 30, 2024, compared to other income of $2.2 million for the nine months ended September 30, 2023. The other income decrease of $0.3 million was primarily related to a decrease in interest income.
Previous wording
We have not generated any product revenue and have incurred net losses and negative cash flows from our operations. As of June 30, 2024, we had cash, cash equivalents and marketable securities of $52.3 million. We have financed our operations through sales of our common stock, convertible preferred stock and convertible debt. Our net loss was $15.1 million and $19.6 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $247.0 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures.
Current wording
We have not generated any product revenue and have incurred net losses and negative cash flows from our operations. As of September 30, 2024, we had cash, cash equivalents and marketable securities of $47.0 million. We have financed our operations through sales of our common stock, convertible preferred stock and convertible debt. Our net loss was $22.4 million and $26.7 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $254.3 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures.
Previous wording
During the six months ended June 30, 2024, net cash used in operating activities was $13.4 million, primarily resulting from our $15.1 million net loss and a $1.3 million decrease in our operating assets and liabilities partially offset by increases in non-cash charges of $3.1 million, primarily related to $2.0 million of stock compensation expense, $0.8 million of non-cash lease expense, $0.4 million for amortization of financing lease right-of-use assets, and $0.3 million for depreciation and amortization, partially offset by $0.4 million of accretion on marketable securities. During the six months ended June 30, 2023, net cash used in operating activities was $21.2 million, primarily resulting from our $19.6 million net loss and a $4.9 million decrease in our operating assets and liabilities partially offset by increases in non-cash charges of $3.3 million primarily related to $2.3 million of stock compensation expense, $0.7 million of non-cash lease expense, $0.4 million for amortization of financing lease right-of-use assets, $0.3 million relating to fixed asset disposition and $0.3 million for depreciation and amortization, primarily offset by $0.7 million of accretion on marketable securities.
Current wording
During the nine months ended September 30, 2024, net cash used in operating activities was $18.9 million, primarily resulting from our $22.4 million net loss and a $0.7 million decrease in our operating assets and liabilities partially offset by increases in non-cash charges of $4.3 million, primarily related to $2.7 million of stock compensation expense, $1.2 million of non-cash lease expense, $0.6 million for amortization of financing lease right-of-use assets, and $0.4 million for depreciation and amortization, partially offset by $0.6 million of accretion on marketable securities. During the nine months ended September 30, 2023, net cash used in operating activities was $25.9 million, primarily resulting from our $26.7 million net loss and a $3.9 million decrease in our operating assets and liabilities partially offset by increases in non-cash charges of $4.8 million, primarily related to $3.4 million of stock compensation expense, $1.0 million of non-cash lease expense, $0.6 million for amortization of financing lease right-of-use assets, $0.4 million for depreciation and amortization and $0.3 million relating to fixed asset disposition, primarily offset by $0.9 million of accretion on marketable securities.
Previous wording
During the six months ended June 30, 2024, net cash provided by investing activities was $12.7 million, primarily due to $30.8 million in maturities of short-term investments, partially offset by $18.0 million in purchases of short-term investments and $0.1 million of purchases of property and equipment. During the six months ended June 30, 2023, net cash provided by investing activities was $21.8 million primarily due to $31.7 million in maturities of short-term investments and $0.2 million for proceeds from the sale of equipment, partially offset by $9.8 million in purchases of short-term investments and $0.2 million in purchases of property and equipment.
Current wording
During the nine months ended September 30, 2024, net cash provided by investing activities was $25.6 million, primarily due to $52.5 million in maturities of short-term investments, partially offset by $26.8 million in purchases of short-term investments and $0.1 million of purchases of property and equipment. During the nine months ended September 30, 2023, net cash provided by investing activities was $30.2 million primarily due to $48.7 million in maturities of short-term investments and $0.2 million for proceeds from the sale of equipment, partially offset by $18.5 million in purchases of short-term investments and $0.2 million in purchases of property and equipment.
Previous wording
During the six months ended June 30, 2024, net cash used in financing activities was $0.4 million, primarily consisting of $0.4 million of principal payments under our financing leases. During the six months ended June 30, 2023, net cash used in financing activities was $8.2 million, primarily from $7.8 million of payments relating to the repurchase of shares of our common stock and $0.4 million of principal payments under our financing leases.
Current wording
During the nine months ended September 30, 2024, net cash used in financing activities was $0.6 million, primarily consisting of $0.6 million of principal payments under our financing leases. During the nine months ended September 30, 2023, net cash used in financing activities was $10.7 million, primarily from $10.1 million of payments relating to the repurchase of shares of our common stock and $0.6 million of principal payments under our financing leases.
Previous wording
Our material cash requirements will have an impact on our future liquidity. Our material cash requirements represent material expected or contractually committed future payment obligations. We believe that we will be able to fund these obligations through cash from our existing balances of cash, cash equivalents and marketable securities.
Current wording
Our material cash requirements will have an impact on our future liquidity. Our material cash requirements represent material expected or contractually committed future payment obligations.
Previous wording
We have operating lease arrangements for our corporate offices, lab facilities and an executive residence. As part of our adoption of ASC 842, we recorded operating right-of-use assets and operating lease liabilities for these leases as of January 1, 2022. As of June 30, 2024, we had operating lease payment obligations of $4.1 million, with $0.9 million payable for the remainder of 2024. See Note 6 in our condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
Current wording
We have operating lease arrangements for our corporate offices, lab facilities and an executive residence. As part of our adoption of ASC 842, we recorded operating right-of-use assets and operating lease liabilities for these leases as of January 1, 2022. As of September 30, 2024, we had operating lease payment obligations of $3.7 million, with $0.5 million payable for the remainder of 2024. See Note 6 in our condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
Previous wording
We lease research equipment, furniture and a vehicle under finance leases. As part of our adoption of ASC 842, we recorded financing right-of-use assets and financing lease liabilities for these leases as of January 1, 2022. As of June 30, 2024, we had finance lease payment obligations of $1.3 million, with $0.4 million payable for the remainder of 2024. See Note 6 in our condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
Current wording
We lease research equipment, furniture and a vehicle under finance leases. As part of our adoption of ASC 842, we recorded financing right-of-use assets and financing lease liabilities for these leases as of January 1, 2022. As of September 30, 2024, we had finance lease payment obligations of $1.1 million, with $0.2 million payable for the remainder of 2024. See Note 6 in our condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
Previous wording
We expect our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. We have based this estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:
Current wording
We expect our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2026. We have based this estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:
Previous wording
We define our critical accounting policies as those accounting principles that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the six months ended June 30, 2024, there were no significant changes to our critical accounting policies disclosed in our audited financial statements for the year ended December 31, 2023, which are included in our Annual Report on Form 10-K, as filed with the SEC on February 29, 2024.
Current wording
We define our critical accounting policies as those accounting principles that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the nine months ended September 30, 2024, there were no significant changes to our critical accounting policies disclosed in our audited financial statements for the year ended December 31, 2023, which are included in our Annual Report on Form 10-K, as filed with the SEC on February 29, 2024.