Sensei Biotherapeutics Inc

Previous wording

We have completed enrollment in the dose escalation portion of the Phase 1/2 clinical trial, enrolling 16 patients in the monotherapy arm and 18 patients in the combination arm.

Current wording

In May 2024, we presented clinical data from the dose escalation portion of the trial at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Data were presented from a total of 34 patients who received SNS-101 once every 3 weeks, with 16 patients in the monotherapy arm and 18 patients in the combination arm. The majority of patients (85%) had a tumor type that is typically unresponsive to PD-1 monotherapy.

Previous wording

In January 2024, we announced the expansion of the Phase 1/2 clinical trial of SNS-101 to include additional patients in a more focused set of indications. Prior to initiating the Phase 2 portion, we plan to enroll up to an aggregate of 40 additional patients across both the monotherapy and combination arms to further optimize the Phase 2 trial design. In the monotherapy expansion arm, we are enrolling up to 10 patients with microsatellite stable (MSS) colorectal cancer (CRC) at a dose level of 15 mg/kg. In the combination expansion arm, we are enrolling up to 30 patients with MSS CRC, Head and Neck cancer, non-small cell lung cancer, and melanoma at a dose level of 15 mg/kg plus Libtayo. Enrollment in the expansion cohorts has commenced, and we are considering enrolling additional patients with other tumor types and/or at other dose levels for both the monotherapy and combination expansion arms. We expect to report initial data from the expansion cohorts and hold an end-of-Phase 1 meeting with the FDA by the end of 2024.

Current wording

We expect to report initial data from the dose expansion cohorts and hold an end-of-Phase 1 meeting with the FDA by the end of 2024.

Previous wording

In connection with the expansion of the Phase 1/2 trial of SNS-101, we paused the IND-enabling studies originally planned for our next TMAb product candidate. With this realignment of resources, we expect our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. Preclinical work on our TMAb product candidates to characterize selected lead antibodies, including their mechanisms of action, and target biology is expected to continue throughout 2024. We plan to continue reviewing our financial resources with the expectation that IND-enabling studies for additional TMAb product candidates will resume if we raise sufficient additional capital.

Current wording

In January 2024, we announced the expansion of the Phase 1/2 clinical trial of SNS-101 to include additional patients in a more focused set of indications. Prior to initiating the Phase 2 portion, we now plan to enroll up to an aggregate of 50 to 70 additional patients across both the monotherapy and combination arms to further optimize the Phase 2 trial design. In connection with the expansion of the Phase 1/2 trial of SNS-101, we paused the IND-enabling studies originally planned for our next TMAb product candidate. With this realignment of resources, we expect our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. Preclinical work on our TMAb product candidates to characterize selected lead antibodies, including their mechanisms of action, and target biology is expected to continue throughout 2024. We plan to continue reviewing our financial resources with the expectation that IND-enabling studies for additional TMAb product candidates will resume if we raise sufficient additional capital.

Previous wording

We have incurred significant operating losses over the last several years. Our net loss was $8.0 million and $10.2 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, we had an accumulated deficit of $239.9 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 $15.1 million and $19.6 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $247.0 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:

Previous wording

Other income was $0.7 million for the three months ended March 31, 2024, compared to other income of $0.8 million for the three months ended March 31, 2023. The other income decrease of $0.1 million was primarily related to a $0.2 million decrease in interest income offset by a $0.1 million increase related to disposals of equipment.

Current wording

Other income was $0.6 million for the three months ended June 30, 2024, compared to other income of $0.8 million for the three months ended June 30, 2023. The other income decrease of $0.1 million was primarily related to a $0.2 million decrease in interest income offset by a $0.1 million related to a loss on disposals of equipment in 2023.

Previous wording

Research and development expenses were $4.9 million for the three months ended March 31, 2024, compared to $5.2 million for the three months ended March 31, 2023. The decrease of $0.3 million was primarily attributable to $0.6 million lower manufacturing related expense, $0.5 million of lower costs for preclinical research, $0.3 million of lower facilities expense and $0.3 million of less consulting fees, primarily offset by $0.7 million of higher expense associated with clinical trials, $0.6 million of increased outside research fees and $0.1 million higher expense relating to relating to lab supply purchases.

Current wording

Research and development expenses were $9.5 million for the six months ended June 30, 2024, compared to $10.0 million for the six months ended June 30, 2023. The decrease of $0.5 million was primarily attributable to $0.8 million of lower costs for preclinical research, $0.6 million lower manufacturing related expense, $0.5 million of less consulting fees, $0.4 million of lower facilities expense, $0.1 million of lower outside research fees, $0.1 million of less licensing fees and $0.1 million of lower restructuring costs, primarily offset by $1.7 million of higher expense associated with clinical trials, $0.3 million of higher personnel costs, including stock-based compensation and incentives, and $0.1 million higher expense relating to lab supply purchases.

Previous wording

General and administrative expenses were $3.8 million for the three months ended March 31, 2024, compared to $5.8 million for the three months ended March 31, 2023. The decrease of $2.0 million was primarily attributable to $1.5 million of lower external professional services associated with stockholder activism related to our 2023 annual meeting of stockholders, $0.2 million less expense for directors and officers insurance, $0.2 million of lower expense for outside services, $0.1 million of lower personnel costs, including stock-based compensation and incentives, $0.1 million of less consulting fees and $0.1 million related to lower restructuring costs, partially offset by $0.2 million of higher facilities expense.

Current wording

General and administrative expenses were $7.0 million for the six months ended June 30, 2024, compared to $11.2 million for the six months ended June 30, 2023. The decrease of $4.2 million was primarily attributable to $3.0 million of lower external professional services associated with stockholder activism related to our 2023 annual meeting of stockholders, $0.6 million of lower personnel costs, including stock-based compensation and incentive, $0.4 million less expense for directors and officers insurance, $0.2 million of lower consulting costs, $0.1 million lower restructuring costs and $0.1 million of lower expense for outside services, partially offset by $0.2 million of higher facilities expense.

Previous wording

We have not generated any product revenue and have incurred net losses and negative cash flows from our operations. As of March 31, 2024, we had cash, cash equivalents and marketable securities of $58.1 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 $8.0 million and $10.2 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, we had an accumulated deficit of $239.9 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 June 30, 2024, we had cash, cash equivalents and marketable securities of $52.3 million. We have financed our operations through sales of our common stock, convertible preferred stock and convertible debt. Our net loss was $15.1 million and $19.6 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $247.0 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures.

Previous wording

During the three months ended March 31, 2024, net cash used in operating activities was $7.6 million, primarily resulting from our $8.0 million net loss and a $1.4 million decrease in our operating assets and liabilities partially offset by increases in non-cash charges of $1.8 million, primarily related to $1.2 million of stock compensation expense, $0.4 million of non-cash lease expense, $0.2 million for amortization of financing lease right-of-use assets, and $0.1 million for depreciation and amortization, partially offset by $0.1 million of accretion on marketable securities. During the three months ended March 31, 2023, net cash used in operating activities was $11.7 million, primarily resulting from our $10.2 million net loss and a $3.2 million increase in our operating assets and liabilities partially offset by increases in non-cash charges of $1.6 million which included $1.2 million of stock compensation expense, $0.3 million of non-cash lease expense, $0.2 million related to amortization on financing lease right-of-use assets and $0.2 million depreciation and amortization, partially offset by $0.3 million of accretion on marketable securities.

Current wording

During the six months ended June 30, 2024, net cash used in operating activities was $13.4 million, primarily resulting from our $15.1 million net loss and a $1.3 million decrease in our operating assets and liabilities partially offset by increases in non-cash charges of $3.1 million, primarily related to $2.0 million of stock compensation expense, $0.8 million of non-cash lease expense, $0.4 million for amortization of financing lease right-of-use assets, and $0.3 million for depreciation and amortization, partially offset by $0.4 million of accretion on marketable securities. During the six months ended June 30, 2023, net cash used in operating activities was $21.2 million, primarily resulting from our $19.6 million net loss and a $4.9 million decrease in our operating assets and liabilities partially offset by increases in non-cash charges of $3.3 million primarily related to $2.3 million of stock compensation expense, $0.7 million of non-cash lease expense, $0.4 million for amortization of financing lease right-of-use assets, $0.3 million relating to fixed asset disposition and $0.3 million for depreciation and amortization, primarily offset by $0.7 million of accretion on marketable securities.

Previous wording

During the three months ended March 31, 2024, net cash provided by investing activities was $5.8 million, primarily due to $12.1 million in maturities of short-term investments, partially offset by $6.3 million in purchases of short-term investments. During the three months ended March 31, 2023, net cash provided by investing activities was $2.3 million primarily due to $12.3 million in sales and maturities of short-term investments, partially offset by $9.8 million in purchases of short-term investments and $0.2 million in purchases of property and equipment.

Current wording

During the six months ended June 30, 2024, net cash provided by investing activities was $12.7 million, primarily due to $30.8 million in maturities of short-term investments, partially offset by $18.0 million in purchases of short-term investments and $0.1 million of purchases of property and equipment. During the six months ended June 30, 2023, net cash provided by investing activities was $21.8 million primarily due to $31.7 million in maturities of short-term investments and $0.2 million for proceeds from the sale of equipment, partially offset by $9.8 million in purchases of short-term investments and $0.2 million in purchases of property and equipment.

Previous wording

During the three months ended March 31, 2024, net cash used in financing activities was $0.2 million, primarily consisting of $0.2 million of principal payments under our financing leases. During the three months ended March 31, 2023, net cash used in financing activities was $0.3 million, primarily from $0.2 million of principal payments under our financing leases and $0.1 million for the payment of equity related tax withholdings on behalf of employees.

Current wording

During the six months ended June 30, 2024, net cash used in financing activities was $0.4 million, primarily consisting of $0.4 million of principal payments under our financing leases. During the six months ended June 30, 2023, net cash used in financing activities was $8.2 million, primarily from $7.8 million of payments relating to the repurchase of shares of our common stock and $0.4 million of principal payments under our financing leases.

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 March 31, 2024, we had operating lease payment obligations of $4.6 million, with $1.4 million payable for the remainder of 2024. See Note 6 in our condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.

Current wording

We have operating lease arrangements for our corporate offices, lab facilities and an executive residence. As part of our adoption of ASC 842, we recorded operating right-of-use assets and operating lease liabilities for these leases as of January 1, 2022. As of June 30, 2024, we had operating lease payment obligations of $4.1 million, with $0.9 million payable for the remainder of 2024. See Note 6 in our condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.

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 March 31, 2024, we had finance lease payment obligations of $1.5 million, with $0.7 million payable for the remainder of 2024. See Note 6 in our condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.

Current wording

We lease research equipment, furniture and a vehicle under finance leases. As part of our adoption of ASC 842, we recorded financing right-of-use assets and financing lease liabilities for these leases as of January 1, 2022. As of June 30, 2024, we had finance lease payment obligations of $1.3 million, with $0.4 million payable for the remainder of 2024. See Note 6 in our condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.

Previous wording

We expect our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. We have based this estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:

Current wording

We expect our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. We have based this estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:

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 three months ended March 31, 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 six months ended June 30, 2024, there were no significant changes to our critical accounting policies disclosed in our audited financial statements for the year ended December 31, 2023, which are included in our Annual Report on Form 10-K, as filed with the SEC on February 29, 2024.