Sensei Biotherapeutics, Inc.
For the period ended Sep 30, 2025. Filed Nov 14, 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.
Sep 30, 2025 · Filed Nov 14, 2025
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 2025-06-30; filed 2025-08-05.
0000950170-25-103101
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0001193125-25-281590
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 138 previous paragraphs and 111 current paragraphs.
71 unchanged; 24 reworded; 15 added; 42 removed; 1 previous and 1 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 (15)
Current report
On October 30, 2025, we announced the discontinuation of development of our lead product candidate, solnerstotug, and initiated a comprehensive review of strategic alternatives to maximize stockholder value. These alternatives include, but are not limited to, a sale of assets, licensing arrangements, collaborations, a sale of the Company, a business combination, a merger, or an orderly wind-down of operations.
Current report
On November 14, 2025, we announced the implementation of a workforce reduction to preserve cash, pursuant to which we reduced our workforce by approximately 65% (the “2025 Workforce Reduction”). We expect to incur aggregate cash charges of approximately $1.6 million in connection with the 2025 Workforce Reduction, primarily consisting of severance payments and other employee termination-related expenses, with the remaining employees forming a small team to assist in exploring strategic alternatives and managing compliance with regulatory and financial reporting requirements.
Current report
We are devoting substantial time and resources to the strategic review. Despite devoting significant efforts to identify and evaluate potential strategic alternatives, 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 definitive timeline 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 additional cash distribution to our stockholders. If a strategic transaction is not completed, including if our board of directors determines that no potential transactions or counterparties would be in the best interests of our stockholders, our board of directors may decide to pursue a dissolution and liquidation.
Current report
Our pipeline consists of one clinical-stage program and three preclinical programs.
Current report
On October 17, 2025, we disclosed results from the dose expansion portion of our Phase 1/2 trial of solnerstotug. The Phase 1 dose expansion is a multi-center, open-label study evaluating solnerstotug as monotherapy and in combination with Libtayo® (cemiplimab), Regeneron’s PD-1 inhibitor. The study enrolled patients with a basket of “hot” tumor types (that typically respond to immunotherapy) (n=44), of whom 41 had previously received and progressed on PD-(L)1 therapy, as well as patients with “cold” tumor types (that typically exhibit primary resistance to immunotherapy) (n=20).
Current report
As of the September 8, 2025 data cutoff, 35 efficacy-evaluable “hot” tumor patients had received cemiplimab with either 15 mg/kg (n=19) or 3 mg/kg dose (n=16) of solnerstotug. Six clinical responses, including five in patients with PD-(L)1 resistant tumors, occurred at the higher 15 mg/kg solnerstotug dose, and no objective responses were observed at the 3 mg/kg dose.
Current report
Among 41 “hot” tumor patients that received and progressed on a prior PD-(L)1 therapy, the overall 6-month PFS rate was 37%, which compares favorably with historical benchmarks in this setting. At 15 mg/kg, 6-month PFS reached 50% among PD-(L)1 resistant patients, surpassing rates historically seen in this treatment-refractory population. At 3 mg/kg, 6-month PFS was 24% among PD-(L)1 resistant patients.
Current report
On October 30, 2025, we announced our intention to discontinue development of solnerstotug and terminate the Phase 1/2 trial in an orderly manner.
Current report
Going Concern
Current report
We generally expect that our general and administrative expenses will decrease as we discontinue development of solnerstotug and wind down our clinical operations, including through the implementation of our 2025 Workforce Reduction. However, we may also incur other charges or cash expenditures due to events that may occur as a result of, or associated with, our wind down of clinical operations and review of strategic alternatives. The exact amounts of the charges and costs that we expect to incur, and the timing thereof, are currently unknown and such costs and charges could be material to our results of operation and financial condition.
Current report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Current report
We have discontinued development of solnerstotug and initiated a comprehensive review of strategic alternatives aimed at maximizing stockholder value. We are exploring a range of strategic alternatives that may include, among other options, a sale of assets, licensing arrangements, collaborations, a sale of the company, a business combination, a merger, or an orderly wind-down of operations.
Current report
As part of the cash preservation associated with the strategic review process, we have implemented a reduction in force of approximately 65% of our workforce. We estimate that we will incur cash expenditures of $1.6 million, primarily consisting of severance payments and other employee termination-related expenses, which we expect to recognize the majority of such costs in the fourth quarter of 2025, with the remaining employees forming a small team to assist in exploring strategic alternatives and managing compliance with regulatory and financial reporting requirements. We expect to incur additional losses in the future to fund our operations during the exploration of strategic alternatives. Failure to manage discretionary spending or execute on a strategic alternative may adversely impact our ability to achieve our intended business objectives.
Current report
As of September 30, 2025, we had cash, cash equivalents and marketable securities of $25.0 million. Depending on the outcome of our strategic review process, we may need to raise substantial additional capital to fund our future operations. However, we cannot guarantee that we will be able to obtain sufficient additional funding or that if we do obtain additional funding, that such funding will be obtainable on terms satisfactory to us.
Current report
If, for any reason, we utilize our capital resources more quickly than anticipated or are unable to obtain additional funding on a timely basis and/or complete a strategic transaction, we may be required to further revise our business plan and strategy or cease operations. This may limit the strategic options available to us. As a result, our business, financial condition, and results of operations could be materially affected.
Removed paragraphs (42)
Previous report
We currently have one investigational product candidate, solnerstotug, in clinical development, and three preclinical product candidates.
Previous report
In May 2023, we initiated a first-in-human Phase 1/2 open-label, multi-center, dose escalation and expansion trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of solnerstotug as monotherapy and/or in combination with cemiplimab in patients with advanced solid tumors.
Previous report
On March 27, 2025, we disclosed clinical data from the dose expansion portion of the clinical trial, showing favorable activity in patients with PD-(L)1 resistant “hot” tumors.
Previous report
As of May 1, 2025 an aggregate of 97 patients have been dosed in the Phase 1 portion of the clinical trial, consisting of 34 patients in the dose escalation cohort and 64 patients in the dose expansion cohort. The 64 patients in the dose expansion cohort consist of:
Previous report
10 microsatellite stable (MSS) CRC patients in the monotherapy arm; and
Previous report
54 patients in the cemiplimab combination arm, consisting of 10 MSS CRC patients and 44 PD-(L)1 resistant “hot” tumor patients. 41 out of 44 patients in the “hot” tumor cohort had received and progressed on a prior PD-(L)1 inhibitor.
Previous report
Enrollment in the Phase 1 portion of the clinical trial is now complete, and we expect to present updated clinical data from the dose expansion cohort, including 6-month progression free survival, by the end of 2025.
Previous report
o
Previous report
Subject to our ability to raise sufficient additional capital, we are planning to initiate Phase 2 studies of solnerstotug in 2026, with the trial design and patient selection strategies to be informed by the ongoing dose expansion portion of the trial.
Previous report
In November 2024, we announced a plan to decrease operating expenses, streamline operations and focus resources on advancing the clinical development of solnerstotug (the “Restructuring”). As a result, we closed our research site in Rockville, Maryland, reduced our workforce by approximately 46%, with most headcount reductions affecting our preclinical research and development group, and paused 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.
Previous report
conduct clinical trials of product candidates, including solnerstotug;
Previous report
invest in our TMAb platform;
Previous report
seek to discover and develop additional product candidates or acquire or in-license drugs, product candidates or technologies;
Previous report
seek regulatory approvals for any product candidates that successfully complete clinical trials;
Previous report
ultimately establish a sales, marketing and distribution infrastructure and scale up manufacturing capabilities to commercialize any product candidates for which we may obtain regulatory approval;
Previous report
manufacture our product candidates or otherwise secure the clinical and commercial supply of our product candidates;
Previous report
hire additional research and development and selling, general and administrative personnel;
Previous report
incur costs associated with operating as a public company.
Previous report
We anticipate that our general and administrative expenses will decrease slightly due to reduced payroll costs following the Restructuring. Infrastructure costs are expected to remain consistent, and other expenditures including consulting, legal, tax-related services, accounting, investor relations, and insurance premiums are expected to align with last year’s levels.
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024
Previous report
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, initiate clinical trials of, and potentially seek marketing approval for, our product candidates. In addition, we expect to continue to incur significant costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses. The timing and amount of our operating expenditures will depend largely on:
Previous report
the initiation, progress, timing, costs and results of current and future preclinical studies and clinical trials for our current and future product candidates;
Previous report
the cost and timing of the manufacture of additional clinical trial material as well as any costs related to the scale-up of manufacturing activities;
Previous report
the costs to seek regulatory approvals for any product candidates that successfully complete clinical trials;
Previous report
the need to hire additional clinical, quality assurance, quality control and other scientific personnel;
Previous report
the number and characteristics of product candidates that we develop or may in-license;
Previous report
the outcome, timing and cost of meeting and maintaining compliance with regulatory requirements;
Previous report
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
Previous report
the terms of any collaboration agreements we may choose to enter into, including the achievement of milestones or occurrence of other developments that trigger payments under any license or collaboration agreements we might have at such time;
Previous report
the cost associated with the expansion of our operational, financial and management systems and increased personnel, including personnel to support our operations as a public company; and
Previous report
the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products, if approved, on our own.
Previous report
the scope, progress, results and costs of product discovery, preclinical studies and clinical trials;
Previous report
the scope, prioritization and number of our research and development programs;
Previous report
the costs, timing and outcome of regulatory review of our product candidates;
Previous report
our ability to establish and maintain collaborations on favorable terms, if at all;
Previous report
the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under collaboration agreements, if any;
Previous report
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
Previous report
the extent to which we acquire or in-license other product candidates and technologies;
Previous report
the costs of securing manufacturing arrangements for commercial production; and
Previous report
the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our product candidates.
Showing the first 40 of 42 passages. Open the source sections for the rest.
Reworded paragraphs (24)
Previous 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. 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 that has been focused on the discovery and development of next-generation therapeutics for cancer patients.
Previous wording
We have incurred significant operating losses over the last several years. Our net loss was $11.8 million and $15.1 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $273.9 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 $16.4 million and $22.4 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $278.4 million.
Previous wording
Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses. We expect to continue to incur net losses and negative cash flows for the foreseeable future, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase. In particular, we expect our expenses to increase as we continue our development of, and seek regulatory approvals for, our product candidates, as well as hire additional personnel, pay fees to outside consultants, lawyers and accountants, and incur other increased costs associated with being a public company. In addition, if we seek and obtain regulatory approval to commercialize any product candidate, we will also incur increased expenses in connection with commercialization and marketing of any such product.
Current wording
Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses. We expect to continue to incur net losses and negative cash flows for the foreseeable future, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will decrease.
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 over the next several years as we conduct our clinical trials, prepare regulatory filings for our product candidates and have increased costs associated with manufacturing.
Current wording
Our direct external research and development expenses consist primarily of third party 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. Research and development activities have been central to our business model, prior to our decision to wind down clinical operations in October 2025. We generally expect that our research and development expenses will decrease as we wind down these operations. We may also incur other charges or cash expenditures due to events that may occur as a result of, or associated with, our wind down of clinical operations and review of strategic alternatives. The exact amounts of the charges and costs that we expect to incur, and the timing thereof, are currently unknown and such costs and charges could be material to our results of operation and financial condition.
Previous wording
We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development. Product commercialization will take several years and significant additional development costs.
Current wording
Our expenditures are subject to additional uncertainties, including the terms and timing of regulatory approvals. We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development. Product commercialization will take several years and significant additional development costs.
Previous wording
Research and development expenses were $2.5 million for the three months ended June 30, 2025, compared to $4.6 million for the three months ended June 30, 2024. The decrease of $2.1 million was primarily attributable to $0.8 million of lower personnel costs, including stock-based compensation and incentives, $0.4 million of lower facilities and equipment cost, $0.3 million less expense relating to relating to lab supply purchases, $0.3 million of lower manufacturing costs and $0.3 million less outside research fees.
Current wording
Research and development expenses were $2.5 million for the three months ended September 30, 2025, compared to $4.6 million for the three months ended September 30, 2024. The decrease of $2.1 million was primarily attributable to $0.8 million of lower personnel costs, including stock-based compensation and incentives, $0.4 million less expense associated with clinical trials, $0.3 million of lower facilities and equipment cost, $0.2 million less expense relating to lab supply purchases, $0.2 million of lower preclinical research, $0.1 million of lower manufacturing costs and $0.1 million of lower outside research fees.
Previous wording
General and administrative expenses were $2.7 million for the three months ended June 30, 2025, compared to $3.2 million for the three months ended June 30, 2024. The decrease of $0.5 million was primarily attributable to $0.3 million of lower personnel costs, including stock-based compensation and incentives, $0.1 million for decreased external administrative fees and $0.1 million less license fees.
Current wording
General and administrative expenses were $2.3 million for the three months ended September 30, 2025, compared to $3.2 million for the three months ended September 30, 2024. The decrease of $0.9 million was primarily attributable to $0.7 million of lower personnel costs, including recruiting, stock-based compensation and incentives, $0.1 million of lower consulting fees and $0.1 million of lower facilities and equipment cost.
Previous wording
Other income was $0.3 million for the three months ended June 30, 2025, compared to other income of $0.6 million for the three months ended June 30, 2024. The decrease of $0.4 million was primarily related to a decrease in interest income.
Current wording
Other income was $0.3 million for the three months ended September 30, 2025, compared to other income of $0.6 million for the three months ended September 30, 2024. The decrease of $0.3 million was primarily related to a decrease in interest income.
Previous wording
The following sets forth our results of operations for the six months ended June 30, 2025 and 2024:
Current wording
The following sets forth our results of operations for the nine months ended September 30, 2025 and 2024:
Previous wording
Research and development expenses were $6.3 million for the six months ended June 30, 2025, compared to $9.5 million for the six months ended June 30, 2024. The decrease of $3.2 million was primarily attributable to $1.6 million of lower personnel costs, including stock-based compensation and incentives, $0.8 million of lower facilities and equipment cost, $0.6 million less expense relating to relating to lab supply purchases, $0.3 million of lower manufacturing cost, $0.3 million less outside research fees , $0.1 million of lower preclinical research expense and $0.1 million of lower consulting fees, partially offset by $0.6 million of higher expense associated with clinical trials.
Current wording
Research and development expenses were $8.8 million for the nine months ended September 30, 2025, compared to $14.1 million for the nine months ended September 30, 2024. The decrease of $5.3 million was primarily attributable to $2.4 million of lower personnel costs, including stock-based compensation and incentives, $1.1 million of lower facilities and equipment cost, $0.8 million less expense relating to relating to lab supply purchases, $0.5 million of lower manufacturing cost, $0.4 million less outside research fees and $0.3 million of lower preclinical research expense partially offset by $0.2 million of higher expense associated with clinical trials.
Previous wording
General and administrative expenses were $6.2 million for the six months ended June 30, 2025, compared to $7.0 million for the six months ended June 30, 2024. The decrease of $0.8 million was primarily attributable to $0.9 million of lower personnel costs, including stock-based compensation and incentives, $0.1 million lower cost for external administrative fees, $0.1 million of less expense for directors and officers insurance and $0.1 million of lower board fees, partially offset by $0.3 million of higher consulting cost and $0.1 million of additional facilities and equipment cost.
Current wording
General and administrative expenses were $8.5 million for the nine months ended September 30, 2025, compared to $10.2 million for the nine months ended September 30, 2024. The decrease of $1.7 million was primarily attributable to $1.7 million of lower personnel costs, including recruiting, stock-based compensation and incentives, $0.1 million lower cost for external administrative fees, $0.1 million of less expense for directors and officers insurance and $0.1 million of lower board fees, partially offset by $0.3 million of higher consulting cost.
Previous wording
Other income was $0.7 million for the six months ended June 30, 2025, compared to other income of $1.4 million for the six months ended June 30, 2024. The decrease of $0.7 million was primarily related to a decrease in interest income.
Current wording
Other income was $1.0 million for the nine months ended September 30, 2025, compared to other income of $2.0 million for the nine months ended September 30, 2024. The decrease of $1.0 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, 2025, we had cash, cash equivalents and marketable securities of $28.6 million. We have financed our operations through sales of our common stock, convertible preferred stock and convertible debt. Through the date of this Report, we have raised an aggregate of $123.4 million of gross proceeds from private placements of our equity and convertible debt securities and net proceeds of $138.5 million from our IPO in February 2021. Our net loss was $11.8 million and $15.1 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $273.9 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, 2025, we had cash, cash equivalents and marketable securities of $25.0 million. We have financed our operations through sales of our common stock, convertible preferred stock and convertible debt. Through the date of this Report, we have raised an aggregate of $123.4 million of gross proceeds from private placements of our equity and convertible debt securities and net proceeds of $138.5 million from our IPO in February 2021. Our net loss was $16.4 million and $22.4 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $278.4 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, 2025, net cash used in operating activities was $13.0 million, primarily resulting from our $11.8 million net loss and a $2.3 million decrease in our operating assets and liabilities partially offset by increases in non-cash charges of $1.1 million, primarily related to $0.8 million of non-cash lease expense and $0.7 million of stock compensation expense, partially offset by $0.4 million of accretion on marketable securities.
Current wording
During the nine months ended September 30, 2025, net cash used in operating activities was $16.6 million, primarily resulting from our $16.4 million net loss and a $1.9 million decrease in our operating assets and liabilities partially offset by increases in non-cash charges of $1.7 million, primarily related to $1.1 million of non-cash lease expense, $1.0 million of stock compensation expense and $0.1 million of depreciation and amortization, partially offset by $0.6 million of accretion on marketable securities.
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 increase in our operating assets and liabilities, partially offset by increases in non-cash charges of $3.1 million which included $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.
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 increase 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.
Previous wording
During the six months ended June 30, 2025, net cash provided by investing activities was $15.9 million, primarily due to $24.5 million in maturities of short-term investments and $0.2 million of proceeds from the sale of property and equipment, partially offset by $8.8 million in purchases of short-term investments.
Current wording
During the nine months ended September 30, 2025, net cash provided by investing activities was $17.7 million, primarily due to $36.1 million in maturities of short-term investments and $0.2 million of proceeds from the sale of property and equipment, partially offset by $18.6 million in purchases of short-term investments.
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.
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.
Previous wording
During the six months ended June 30, 2025, net cash used in financing activities was $0.4 million, primarily consisting of $0.5 million of principal payments under our financing leases, partially offset by $0.1 million of proceeds from the sale of financing lease assets.
Current wording
During the nine months ended September 30, 2025, net cash used in financing activities was $0.5 million, primarily consisting of $0.6 million of principal payments under our financing leases, partially offset by $0.1 million of proceeds from the sale of financing lease assets.
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.
Current wording
During the nine months ended September 30, 2024, net cash used in financing activities was $0.6 million, primarily consisting of principal payments under our financing lease.
Previous wording
We have operating lease arrangements for our corporate offices and lab facilities. As part of our adoption of ASC 842, we recorded operating ROU assets and operating lease liabilities for these leases as of January 1, 2022. As of June 30, 2025, we had operating lease payment obligations of $2.3 million, with $0.9 million payable for the remainder of 2025. 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 and lab facilities. As part of our adoption of ASC 842, we recorded operating ROU assets and operating lease liabilities for these leases as of January 1, 2022. As of September 30, 2025, we had operating lease payment obligations of $1.9 million, with $0.4 million payable for the remainder of 2025. 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 and furniture under finance leases. As part of our adoption of ASC 842, we recorded financing ROU assets and financing lease liabilities for these leases as of January 1, 2022. As of June 30, 2025, we had finance lease payment obligations of $0.4 million, with $0.3 million payable for the remainder of 2025. 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 and furniture under finance leases. As part of our adoption of ASC 842, we recorded financing ROU assets and financing lease liabilities for these leases as of January 1, 2022. As of September 30, 2025, we had finance lease payment obligations of $0.2 million, with $0.1 million payable for the remainder of 2025. See Note 6 in our condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
Previous wording
Based on our available cash, cash equivalents, and marketable securities, and our current operating plans excluding any financing, we expect to be able to fund our operating expenses and capital expenditure requirements into the second quarter of 2026. We have concluded that there is substantial doubt about our ability to continue as a going concern beyond one year from the issuance of these financial statements, and we will require additional financing to support our operations, which we may be unable to obtain on favorable terms or at all. 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
Based on our available cash, cash equivalents, and marketable securities, and our current operating plans excluding any financing, we expect that our existing cash and cash equivalents will be unable to fund our operating expenses and capital requirements beyond one year from the issuance of our condensed consolidated financial statements. We have concluded that there is substantial doubt about our ability to continue as a going concern beyond one year from the issuance of the financial statements included in this Quarterly Report on Form 10-Q. We expect our expenses to decrease in connection with the wind down of our clinical operations. However, we may incur substantial additional expenses and other charges as we conduct our strategic alternatives review and evaluate and seek to consummate strategic transactions to maximize stockholder value.
Previous wording
maintain, expand and protect our intellectual property portfolio; and
Current wording
If we are successful in consummating a strategic transaction that enables us to continue to develop our current or new product candidates, we will require substantial additional funding to expand our operations, hire additional personnel, initiate and successfully complete preclinical studies and clinical trials, obtain marketing approval and generate revenue from sales of our product candidates, if approved, and protect our intellectual property. We would expect to finance our operations through the public or private sale of our equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. Because of the uncertain outcome of our strategic review process and the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of our future expenses, and there is no assurance that we will ever be profitable or generate positive cash flow from operating activities.
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, 2025, there were no significant changes to our critical accounting policies disclosed in our audited financial statements for the year ended December 31, 2024, which are included in our Annual Report on Form 10-K, as filed with the SEC on March 28, 2025.
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, 2025, there were no significant changes to our critical accounting policies disclosed in our audited financial statements for the year ended December 31, 2024, which are included in our Annual Report on Form 10-K, as filed with the SEC on March 28, 2025.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Based on our available cash, cash equivalents and marketable securities and current operating plans excluding any financing, we will not have sufficient cash and cash equivalents to fund our operating expenses and capital requirements beyond one year from the issuance of the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, and therefore, we have concluded that there is substantial doubt about its ability to continue as a going concern.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Our expenditures are subject to additional uncertainties, including the terms and timing of regulatory approvals. We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials.