Sensei Biotherapeutics Inc

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 using our robust set of R&D capabilities. We plan to efficiently develop these product candidates by incorporating state-of-the-art biomarker approaches and mechanistic understanding into clinical trial designs targeted to well-defined patient populations.

Current wording

We are a clinical-stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients. Through our TMAb™ (Tumor Microenvironment Activated Biologics) platform, we are developing highly selective therapeutics designed to disable immunosuppressive signals or activate immunostimulatory signals selectively in the tumor microenvironment. Our strategy is to generate novel product candidates that incorporate next-generation technologies or approaches. We plan to efficiently develop these product candidates by incorporating state-of-the-art biomarker approaches and mechanistic understanding into clinical trial designs targeted to well-defined patient populations.

Previous wording

We currently have one investigational product candidate, SNS-101, in clinical development.

Current wording

We currently have one investigational product candidate, solnerstotug, in clinical development, and three preclinical product candidates.

Previous wording

SNS-101 is our conditionally active monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T-cell activation). 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 SNS-101 as monotherapy and/or in combination with cemiplimab in patients with advanced solid tumors.

Current wording

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 wording

In November 2024, we announced a plan to decrease operating expenses, streamline operations and focus resources on advancing the clinical development of SNS-101. As a result, we will close our research site in Rockville, Maryland, reduce our workforce by approximately 46%, with most headcount reductions affecting our preclinical research and development group, and pause further development of our preclinical product candidates, including SNS-102, SNS-103 and SNS-201. With this realignment of resources, we expect our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2026. We plan to continue reviewing our financial resources with the expectation that work on our preclinical product candidates will resume if we raise sufficient additional capital.

Current wording

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 wording

We have incurred significant operating losses over the last several years. Our net loss was $22.4 million and $26.7 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $254.3 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:

Current wording

We have incurred significant operating losses over the last several years. Our net loss was $6.9 million and $8.0 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $268.9 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:

Previous wording

conduct clinical trials of product candidates, including SNS-101;

Current wording

conduct clinical trials of product candidates, including solnerstotug;

Previous wording

Our direct external research and development expenses consist primarily of external costs, such as fees paid to CROs, CMOs, research/testing laboratories and outside consultants in connection with our preclinical development, process development, manufacturing and clinical development activities. We do not allocate these costs to specific product candidates because many of them are deployed across several of our development programs and, as such, are not separately classified. We use internal resources primarily to conduct research and manage our preclinical development, process development, manufacturing and clinical development activities. These employees work across multiple development programs and, therefore, we do not track their costs by program and, as such, are not separately classified. Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to increase significantly over the next several years as we increase personnel costs, including stock-based compensation, conduct our preclinical studies or clinical trials, and prepare regulatory filings for our product candidates.

Current wording

Our direct external research and development expenses consist primarily of external costs, such as fees paid to CROs, CMOs, research/testing laboratories and outside consultants in connection with our preclinical development, process development, manufacturing and clinical development activities. We do not allocate these costs to specific product candidates because many of them are deployed across several of our development programs and, as such, are not separately classified. We use internal resources primarily to conduct research and manage our preclinical development, process development, manufacturing and clinical development activities. These employees work across multiple development programs and, therefore, we do not track their costs by program and, as such, are not separately classified. Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to increase 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.

Previous wording

Our expenditures are subject to additional uncertainties, including the terms and timing of regulatory approvals, and the expense of filing, prosecuting, defending and enforcing any patent claims or other intellectual property rights. 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

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

General and administrative expenses consist principally of salaries and related costs for personnel in executive, administrative, finance and legal functions, including stock-based compensation, travel expenses and recruiting expenses. Other general and administrative expenses include facility related costs, patent filing and prosecution costs and professional fees for legal, auditing and tax services, and insurance costs.

Current wording

General and administrative expenses consist principally of salaries and related costs for personnel in executive, administrative, finance and legal functions, including stock-based compensation, travel and recruiting expenses. Other general and administrative expenses include facility related costs, patent filing and prosecution costs and professional fees for legal, auditing and tax services, and insurance costs.

Previous wording

Our other income (expense) consists of accretion expense 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 expense and gain or loss on fixed asset disposals.

Previous wording

Research and development expenses were $14.1 million for the nine months ended September 30, 2024, compared to $13.8 million for the nine months ended September 30, 2023. The increase of $0.3 million was primarily attributable to $2.6 million of higher expense associated with clinical trials, $0.5 million of higher personnel costs, including stock-based compensation and incentives, and $0.1 million higher expense relating to lab supply purchases, primarily offset by $1.0 million of lower costs for preclinical research, $0.7 million of less consulting fees, $0.5 million lower manufacturing related expense, $0.4 million of lower facilities expense, $0.1 million of lower outside research fees, $0.1 million of less licensing fees and $0.1 million of lower restructuring costs.

Current wording

Research and development expenses were $3.7 million for the three months ended March 31, 2025, compared to $4.9 million for the three months ended March 31, 2024. The decrease of $1.2 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, $0.2 million of lower preclinical research expense, $0.1 million less outside research fees and $0.1 million of lower manufacturing cost, partially offset by $0.7 million of higher expense associated with clinical trials.

Previous wording

General and administrative expenses were $3.2 million for the three months ended September 30, 2024, compared to $3.9 million for the three months ended September 30, 2023. The decrease of $0.7 million was primarily attributable to $0.2 million less expense for directors and officers insurance, $0.2 million of lower expense for outside services, $0.2 million of lower personnel costs, including recruitment fees, stock-based compensation and incentives, and $0.1 million less license fees.

Current wording

General and administrative expenses were $3.5 million for the three months ended March 31, 2025, compared to $3.8 million for the three months ended March 31, 2024. The decrease of $0.3 million was primarily attributable to $0.6 million of lower personnel costs, including stock-based compensation and incentives, and $0.1 million of less expense for directors and officers insurance, primarily offset by $0.3 million of higher consulting cost and $0.1 million higher cost for external administrative fees.

Previous wording

Other income was $2.0 million for the nine months ended September 30, 2024, compared to other income of $2.2 million for the nine months ended September 30, 2023. The other income decrease of $0.3 million was primarily related to a decrease in interest income.

Current wording

Other income was $0.4 million for the three months ended March 31, 2025, compared to other income of $0.7 million for the three months ended March 31, 2024. The other income decrease of $0.3 million was primarily related to a $0.3 million 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 September 30, 2024, we had cash, cash equivalents and marketable securities of $47.0 million. We have financed our operations through sales of our common stock, convertible preferred stock and convertible debt. Our net loss was $22.4 million and $26.7 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $254.3 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures.

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, 2025, we had cash, cash equivalents and marketable securities of $34.3 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 $6.9 million and $8.0 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $268.9 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.

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 decrease in our operating assets and liabilities partially offset by increases in non-cash charges of $4.3 million, primarily related to $2.7 million of stock compensation expense, $1.2 million of non-cash lease expense, $0.6 million for amortization of financing lease right-of-use assets, and $0.4 million for depreciation and amortization, partially offset by $0.6 million of accretion on marketable securities. During the nine months ended September 30, 2023, net cash used in operating activities was $25.9 million, primarily resulting from our $26.7 million net loss and a $3.9 million decrease in our operating assets and liabilities partially offset by increases in non-cash charges of $4.8 million, primarily related to $3.4 million of stock compensation expense, $1.0 million of non-cash lease expense, $0.6 million for amortization of financing lease right-of-use assets, $0.4 million for depreciation and amortization and $0.3 million relating to fixed asset disposition, primarily offset by $0.9 million of accretion on marketable securities.

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, 2024, net cash provided by investing activities was $25.6 million, primarily due to $52.5 million in maturities of short-term investments, partially offset by $26.8 million in purchases of short-term investments and $0.1 million of purchases of property and equipment. During the nine months ended September 30, 2023, net cash provided by investing activities was $30.2 million primarily due to $48.7 million in maturities of short-term investments and $0.2 million for proceeds from the sale of equipment, partially offset by $18.5 million in purchases of short-term investments and $0.2 million in purchases of property and equipment.

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 $0.6 million of principal payments under our financing leases. During the nine months ended September 30, 2023, net cash used in financing activities was $10.7 million, primarily from $10.1 million of payments relating to the repurchase of shares of our common stock and $0.6 million of principal payments under our financing leases.

Current wording

During the three months ended March 31, 2025 and 2024, 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

Our material cash requirements will have an impact on our future liquidity. Our material cash requirements represent material expected or contractually committed future payment obligations.

Current wording

Our material cash requirements will have an impact on our future liquidity. Our material cash requirements represent material expected or contractually committed future payment obligations. We believe that we will be able to fund these obligations through cash from our existing cash, cash equivalents and marketable securities.

Previous wording

We have operating lease arrangements for our corporate offices, lab facilities and an executive residence. As part of our adoption of ASC 842, we recorded operating right-of-use assets and operating lease liabilities for these leases as of January 1, 2022. As of September 30, 2024, we had operating lease payment obligations of $3.7 million, with $0.5 million payable for the remainder of 2024. See Note 6 in our condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.

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

Previous wording

We lease research equipment, furniture and a vehicle under finance leases. As part of our adoption of ASC 842, we recorded financing right-of-use assets and financing lease liabilities for these leases as of January 1, 2022. As of September 30, 2024, we had finance lease payment obligations of $1.1 million, with $0.2 million payable for the remainder of 2024. See Note 6 in our condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.

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 March 31, 2025, we had finance lease payment obligations of $0.6 million, with $0.5 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 expect our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2026. We have based this estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:

Current 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:

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, 2024, there were no significant changes to our critical accounting policies disclosed in our audited financial statements for the year ended December 31, 2023, which are included in our Annual Report on Form 10-K, as filed with the SEC on February 29, 2024.

Current wording

We define our critical accounting policies as those accounting principles that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the three months ended March 31, 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.

Previous wording

In addition, the JOBS Act provides that an EGC can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an EGC to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an EGC. Therefore, the reported results of operations contained in our consolidated financial statements may not be directly comparable to those of other public companies.

Current wording

In addition, the JOBS Act provides that an EGC can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an EGC to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an EGC. Therefore, the reported results of operations contained in our condensed consolidated financial statements may not be directly comparable to those of other public companies.