Sensei Biotherapeutics, Inc.
For the period ended Mar 31, 2026. Filed May 15, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 15, 2026
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 2025-09-30; filed 2025-11-14.
0001193125-25-281590
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-15.
0001193125-26-225333
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 111 previous paragraphs and 109 current paragraphs.
52 unchanged; 17 reworded; 39 added; 39 removed; 3 previous and 1 current paragraphs rearranged.
Tables are not compared: 3 previous and 2 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 (39)
Current report
We are a clinical-stage biotechnology company focused on improving outcomes for cancer patients through multi-node inhibition of critical oncogenic pathways. On February 17, 2026, we completed the Acquisition of Faeth Therapeutics, a clinical-stage biotechnology company developing multi-node therapies targeting tumor metabolism and signaling, and received $200 million in gross proceeds from the 2026 Private Placement from a broad syndicate of institutional investors. The acquisition brought Faeth's lead asset, PIKTOR, a proprietary investigational all-oral combination of serabelisib and sapanisertib that inhibits multiple nodes of the PI3K/AKT/mTOR pathway, into our pipeline. For additional information regarding the terms of the acquisition and the concurrent financing, see Note 3 to the condensed consolidated financial statements.
Current report
Following the Acquisition, our lead program is PIKTOR, an oral multi-node inhibitor of the PI3K/AKT/mTOR pathway in development for endometrial and breast cancer. The PI3K/AKT/mTOR pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology. Our core thesis is that simultaneously suppressing multiple pathway nodes can produce deeper, more durable tumor suppression than approved therapies that target only a single node. PIKTOR is currently being evaluated in an ongoing Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated in the second half of 2026, and in April 2026 the first patient was dosed in our Phase 1b/2 trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101), from which we expect to report interim data in 2027. We believe the $200 million in gross financing proceeds, together with our existing cash, cash equivalents and marketable securities, will be sufficient to fund operations through these key clinical milestones.
Current report
Prior to the Acquisition, we were primarily focused on the development of solnerstotug (formerly SNS-101), our conditionally active monoclonal antibody targeting the immune checkpoint VISTA. We are completing the remaining portion of the solnerstotug Phase 1/2 trial with patients currently on study.
Current report
Acquired in-process research and development expense represents the fair value of in-process research and development assets obtained in connection with asset acquisitions where the acquired IPR&D has no alternative future use as of the acquisition date. In accordance with ASC 805, such amounts are expensed at the time of acquisition rather than capitalized. We expect to recognize acquired IPR&D expense in periods in which we consummate acquisitions of development-stage assets. The amount and timing of such charges, if any, will depend on the nature, size and frequency of future acquisition activity.
Current report
Research and development expenses were $18.0 million for the three months ended March 31, 2026, compared to $3.7 million for the three months ended March 31, 2025. The increase of $14.2 million was primarily driven by the inclusion of Faeth Therapeutics operations following the February 2026 acquisition, contributing $1.8 million of research and development costs including preclinical, clinical trial, and chemistry, manufacturing and controls (or "CMC") related expenses, $4.8 million of non-cash stock-based compensation expense and $9.1 million of non-recurring tax gross-up payments related to the accelerated vesting of Faeth options, and $0.7 million of stock-based compensation from inducement grants issued to Faeth employees, partially offset by a $2.2 million decrease in legacy Sensei research and development spending.
Current report
We expect research and development expenses in future periods to be lower than those incurred during the three months ended March 31, 2026, which included significant non-recurring costs associated with the Acquisition, including stock-based compensation expense related to the accelerated vesting of Faeth employee stock options and tax gross-up payments. However, we expect our ongoing research and development expenses to increase significantly as we advance PIKTOR through our ongoing Phase 2 trial in advanced endometrial cancer and our recently initiated Phase 1b/2 trial in HR+/HER2- advanced breast cancer, and as we expand preclinical and CMC activities for our broader pipeline.
Current report
General and administrative expenses were $19.7 million for the three months ended March 31, 2026, compared to $3.5 million for the three months ended March 31, 2025. The increase of $16.2 million was primarily driven by acquisition-related charges consisting of $6.2 million of non-cash stock-based compensation expense and $6.5 million of non-recurring tax gross-up payments related to the accelerated vesting of Faeth options, $2.5 million of transaction costs, $0.6 million of Faeth operating costs, $0.8 million related to inducement grants issued to Faeth employees and $0.2 million related to assumed options, partially offset by a $0.6 million reduction in legacy Sensei expenses.
Current report
We expect our general and administrative expenses in future periods to be lower than those incurred during the three months ended March 31, 2026, which included significant non-recurring costs associated with the Acquisition, including stock-based compensation expense related to the accelerated vesting of Faeth employee stock options and transaction costs. However, we expect our ongoing general and administrative expenses to remain significantly higher than our pre-Acquisition levels as a result of the integration of Faeth Therapeutics' operations, including personnel costs associated with the expanded workforce and the support of our broader product pipeline, as well as additional costs associated with operating as a larger public company, including consulting, legal, tax-related services, accounting, investor relations, and insurance premiums.
Current report
Acquired in-process research and development expense was $133.0 million for the three months ended March 31, 2026, with no comparable expense in the prior year period. The charge was recognized in connection with the acquisition of Faeth Therapeutics in February 2026 and represents the fair value of acquired IPR&D assets that had no alternative future use as of the acquisition date. See Note 3 to our unaudited condensed consolidated financial statement included elsewhere in this Quarterly Report for additional information regarding the acquisition.
Current report
Other income was $0.4 million for the three months ended March 31, 2026 and 2025. For both periods this primarily consisted of interest income related to securities.
Current report
We expect our cash requirements to increase as we advance PIKTOR through multiple clinical trials following the Acquisition of Faeth Therapeutics, including our ongoing Phase 2 trial in advanced endometrial cancer and our recently initiated Phase 1b/2 trial in HR+/HER2- advanced breast cancer, and we believe our existing cash, cash equivalents and marketable securities of $202.8 million are sufficient to fund operations through topline data readouts from both studies.
Current report
During the three months ended March 31, 2026, net cash provided by financing activities was $185.8 million, primarily consisting of $200.0 million proceeds from the issuance of Series B Preferred Stock, $1.0 million from the exercise of options into common stock, partially offset by $15.1 million of issuance costs from the private placement issuance of Series B Preferred Stock and $0.1 million of principal payments under our financing leases.
Current report
In addition, our future capital requirements will depend on many factors, including, without limitation, the timing of stockholder approval of the Company Stockholder Matters and the potential cash settlement obligations that may arise if we are unable to timely deliver shares of our common stock upon conversion of the Series B Preferred Stock. In connection with the Acquisition, we issued 24,937.493 shares of Series B Preferred Stock, each share of which is convertible into 1,000 shares of our common stock, subject to certain beneficial ownership limitations and receipt of approval of the Company Stockholder Matters. The shares of Series B Preferred Stock will automatically convert upon the third business day following receipt of approval of the Company Stockholder Matters stockholder approval in accordance with Nasdaq listing rules up to the beneficial ownership limitations set by each holder; provided that such beneficial ownership limitations may be waived by each holder of Series B Preferred Stock at any time following the approval by Nasdaq of the Nasdaq Listing Application and approval of the Company Stockholder Matters.
Current report
The Certificate of Designation contains a provision that, at any time following the earlier of (i) approval of the Company Stockholder Matters or (ii) six months after the initial issuance of the Series B Preferred Stock, if we fail to deliver shares of our common stock to a converting holder within the time periods required by the Certificate of Designation, such holder may require us to pay, in lieu of delivering the applicable conversion shares, an amount of cash equal to the fair value of the undelivered shares based on the last reported closing sale price of our common stock on the principal trading market on which our common stock is listed as of the trading day immediately prior to the date on which the applicable notice of conversion was delivered to us. Such payment would be required within two business days of the holder's request.
Current report
If we are unable to obtain approval of the Company Stockholder Matters or approval of the Nasdaq Listing Application, or if we are otherwise unable to timely deliver shares of our common stock upon conversion — whether due to an insufficient number of authorized shares, Nasdaq listing requirements, or other factors — we could become obligated to make significant cash settlement payments to holders of Series B Preferred Stock who submit conversion notices after the applicable trigger date. Given the number of shares of Series B Preferred Stock outstanding and the potential magnitude of such cash settlement obligations, which would be determined by reference to the then-current trading price of our common stock, any such payments could require us to use a substantial portion of our available cash resources or to seek additional financing to satisfy these obligations, which could materially limit the amount of cash available to fund our operations and advance our clinical programs.
Current report
Additionally, even following stockholder approval of the Company Stockholder Matters, certain holders may be unable to convert their shares of Series B Preferred Stock due to the application of beneficial ownership limitations set by such holder. Shares of Series B Preferred Stock that are not converted in the automatic conversion on account of beneficial ownership limitations will remain outstanding until converted at the option of the applicable holder, and the cash settlement provisions described above would apply to any failure to timely deliver conversion shares in connection with any such optional conversion.
Current 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:
Current report
the initiation, progress, timing, costs and results of current and future preclinical studies and clinical trials for our current and future product candidates;
Current 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;
Current report
the costs to seek regulatory approvals for any product candidates that successfully complete clinical trials;
Current report
the need to hire additional clinical, quality assurance, quality control and other scientific personnel;
Current report
the number and characteristics of product candidates that we develop or may in-license;
Current report
the outcome, timing and cost of meeting and maintaining compliance with regulatory requirements;
Current report
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
Current 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;
Current 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
Current 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.
Current report
We expect our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements through topline data readouts from both our ongoing Phase 2 trial of PIKTOR in advanced endometrial cancer (Study FTH-PIK-201) and our recently initiated Phase 1b/2 trial of PIKTOR in HR+/HER2- advanced breast cancer (Study FTH-PIK-101). 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 report
the scope, progress, results and costs of product discovery, preclinical studies and clinical trials;
Current report
the scope, prioritization and number of our research and development programs;
Current report
the costs, timing and outcome of regulatory review of our product candidates;
Current report
our ability to establish and maintain collaborations on favorable terms, if at all;
Current report
the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under collaboration agreements, if any;
Current report
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
Current report
the extent to which we acquire or in-license other product candidates and technologies;
Current report
the costs of securing manufacturing arrangements for commercial production; and
Current report
the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our product candidates.
Current report
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. In addition, debt financing would result in fixed payment obligations.
Current report
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Removed paragraphs (39)
Previous report
We are a clinical-stage biotechnology company that has been focused on the discovery and development of next-generation therapeutics for cancer patients.
Previous 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.
Previous 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.
Previous 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.
Previous report
Our pipeline consists of one clinical-stage program and three preclinical programs.
Previous report
Solnerstotug(formerly referred to as SNS-101) is our conditionally active monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T-cell activation).
Previous report
o
Previous 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).
Previous report
o
Previous 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.
Previous report
o
Previous 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.
Previous report
o
Previous 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.
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.
Previous report
SNS-103 is our conditionally active monoclonal antibody targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1), also known as CD39.
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.
Previous report
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 report
Going Concern
Previous report
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.
Previous 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.
Previous report
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 report
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 report
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 report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Previous report
Research and Development Expenses
Previous report
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 report
General and Administrative Expenses
Previous report
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 report
Other Income
Previous report
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 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.
Previous 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.
Previous report
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 report
Finance Leases
Previous 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.
Previous report
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 report
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 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.
Reworded paragraphs (17)
Previous wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and related notes for the year ended December 31, 2024, which are included in our Annual Report on Form 10-K filed with the SEC on March 28, 2025.
Current wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and related notes for the year ended December 31, 2025, which are included in our Annual Report on Form 10-K filed with the SEC on March 30, 2026.
Previous 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.
Current wording
We have incurred significant operating losses since our inception and expect to continue to incur losses for the foreseeable future. Our net loss was $170.2 million and $6.9 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $453.4 million and cash, cash equivalents and marketable securities of $202.8 million, which includes $183.1 million in net proceeds received in the 2026 Private Placement. The increase in our net loss for the three months ended March 31, 2026 compared to the same prior year period was primarily attributable to $133.0 million of acquired in-process research and development expense recognized in connection with the Acquisition of Faeth Therapeutics, as well as increased research and development and general and administrative expenses resulting from the integration of Faeth's operations, including stock-based compensation expense related to the accelerated vesting of Faeth employee stock options and related tax gross-up payments.
Previous wording
expenses incurred under agreements with contract research organizations, or CROs, as well as investigative sites and consultants that conduct our preclinical studies and clinical trials;
Current wording
expenses incurred under agreements with third-party contract research organizations, or CROs, as well as investigative sites and consultants that conduct our preclinical studies and clinical trials;
Previous wording
the cost of manufacturing our product candidates including the cost of contract manufacturing organizations, or CMOs, that manufacture product for use in our preclinical studies and clinical trials and perform analytical testing, scale-up and other services in connection with our development activities;
Current wording
the cost of manufacturing our product candidates including the cost of third-party contract manufacturing organizations, or CMOs, that manufacture product for use in our preclinical studies and clinical trials and perform analytical testing, scale-up and other services in connection with our development activities;
Previous wording
employee-related expenses, including salaries, benefits and stock-based compensation for employees engaged in the research and development function;
Current wording
employee-related expenses, including salaries, benefits and stock-based compensation, severance costs and other related costs for those employees engaged in the research and development function;
Previous 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.
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. All other external research and development costs, including personnel costs, are not allocated to specific product candidates as they support multiple development programs. We have historically used internal resources primarily to conduct research and manage our preclinical development, process development, manufacturing and clinical development activities. These employees have worked across multiple development programs and, therefore, we have not historically tracked 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.
Previous 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.
Current 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.
Previous wording
Our other income (expense) consists of accretion on short-term investments, interest expense and gain or loss on fixed asset disposals.
Current wording
Our other income (expense) consists of accretion on short-term investments, interest income (expense), gain or loss on fixed asset disposal, and changes in fair value of warrant liabilities.
Previous 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.
Current wording
We have not generated any product revenue and have incurred net losses and negative cash flows from our operations. As of March 31, 2026, we had cash, cash equivalents and marketable securities of $202.8 million. We have financed our operations through sales of our common stock, redeemable convertible preferred stock and convertible debt. Through the date of this Quarterly 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 and an additional $183.1 million in net proceeds received in the 2026 Private Placement. Our net loss was $170.2 million and $6.9 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $453.4 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures and general and administrative expenditures.
Previous 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.
Current wording
During the three months ended March 31, 2026, net cash used in operating activities was $10.7 million, primarily resulting from our $170.2 million net loss partially offset by a $13.3 million increase in our operating assets and liabilities and increases in non-cash charges of $146.2 million, primarily related to $133.0 million of acquired in-process research and development from the acquisition of Faeth Therapeutics, $12.9 million of stock compensation expense and $0.4 million of non-cash lease expense partially offset by $0.1 million of accretion on marketable securities. The change in operating assets and liabilities was primarily related to a $10.7 million decrease in prepaid expenses related to tax gross-up expenses for the accelerated vesting of options and a $2.6 million increase in accrued compensation and employee benefits related to unpaid tax gross-up expenses for the accelerated vesting of options.
Previous 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.
Current wording
During the three months ended March 31, 2025, net cash used in operating activities was $7.1 million, primarily resulting from our $6.9 million net loss and a $0.9 million decrease in our operating assets and liabilities partially offset by increases in non-cash charges of $0.6 million, primarily related to $0.5 million of stock compensation expense and $0.4 million of non-cash lease expense, partially offset by $0.3 million of accretion on marketable securities.
Previous 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.
Current wording
During the three months ended March 31, 2026, net cash used in investing activities was $31.4 million, primarily due to $43.9 million in purchases of short-term investments, partially offset by $6.5 million in cash assumed from the acquisition of Faeth and $6.0 million in maturities of short-term investments.
Previous 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.
Current wording
During the three months ended March 31, 2025, net cash provided by investing activities was $7.2 million, primarily due to $13.5 million in maturities of short-term investments, partially offset by $6.3 million in purchases of short-term investments.
Previous 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.
Current wording
During the three months ended March 31, 2025, net cash used in financing activities was $0.2 million, primarily consisting of $0.2 million of principal payments under our financing leases.
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 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.
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 ROU assets and operating lease liabilities for these leases as of January 1, 2022. As of March 31, 2026, we had operating lease payment obligations of $1.0 million, with $1.0 million payable for the remainder of 2026. See Note 7 in our condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
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 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.
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 three months ended March 31, 2026, we acquired in-process research and development intangible assets in connection with the Faeth Therapeutics merger, which represents a new critical accounting policy not previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 30, 2026. Except for this addition, there were no other significant changes to our critical accounting policies which are included in our Annual Report on Form 10-K.
Previous wording
We qualify as an Emerging Growth Company (“EGC”), as defined in the JOBS Act. As an EGC, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies, including reduced disclosure about our executive compensation arrangements, exemption from the requirements to hold non-binding advisory votes on executive compensation and golden parachute payments and exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.
Current wording
We qualify as an Emerging Growth Company, or EGC, as defined in the JOBS Act. As an EGC, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies, including reduced disclosure about our executive compensation arrangements, exemption from the requirements to hold non-binding advisory votes on executive compensation and golden parachute payments and exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.
Rearranged current paragraphs (1)
Current report — wording carried from 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.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
We do not have any product candidates approved for sale, have not generated any revenue from product sales, and do not expect to generate any revenue from product sales for at least the next several years. We have largely funded our operations with proceeds from the sale of convertible preferred stock, common 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 initial public offering, or IPO, in February 2021.
Previous report — wording carried elsewhere
The following sets forth our results of operations for the nine months ended September 30, 2025 and 2024:
Previous report — wording carried elsewhere
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.