sensei(SNSE) - 2024 Q4 - Annual Results

Sensei Biotherapeutics Reports Full Year 2024 Financial Results and Update on Clinical Progress The company reports promising preliminary efficacy and safety data for solnerstotug in PD-(L)1 resistant tumors, with cash reserves projected into Q2 2026 - Preliminary efficacy data from the Phase 1/2 dose expansion cohort in PD-(L)1 resistant "hot" tumor patients show durable responses and tumor shrinkage[1] - Solnerstotug (formerly SNS-101) continues to demonstrate a favorable safety and tolerability profile[1] - The dose expansion cohort has reached its target enrollment, with full data expected by the end of 2025[1] - The company's cash reserves are projected to support operations into the second quarter of 2026[1] Highlights and Milestones The company achieved significant clinical and scientific milestones for solnerstotug, including positive preliminary efficacy data and completion of dose expansion enrollment Solnerstotug (formerly SNS-101) Clinical Program Solnerstotug is a conditionally active antibody designed to selectively target the VISTA immune checkpoint within the tumor microenvironment, currently evaluated in a Phase 1/2 trial as monotherapy and in combination with Libtayo® for advanced solid tumors - Solnerstotug is a conditionally active antibody designed to selectively target the VISTA immune checkpoint within the tumor microenvironment (TME)[4] - The company is conducting a Phase 1/2 clinical trial evaluating the safety and efficacy of solnerstotug as monotherapy and in combination with Libtayo® (cemiplimab)[5] Preliminary Activity in PD-(L)1 Resistant 'Hot' Tumors As of March 17, 2025, the combination of solnerstotug and cemiplimab demonstrated a 14% objective response rate (ORR) and 62% disease control rate (DCR) in 21 evaluable PD-(L)1 resistant "hot" tumor patients, significantly exceeding historical data with a favorable safety profile and no dose-limiting toxicities Preliminary Efficacy Data in PD-(L)1 Resistant 'Hot' Tumor Patients (As of March 17, 2025) | Metric | Result | | :--- | :--- | | Objective Response Rate (ORR) | 14% | | Disease Control Rate (DCR) | 62% | | Complete Response (CR) | 1 case (Merkel cell carcinoma) | | Partial Response (PR) | 2 cases (1 Merkel cell carcinoma, 1 MSI-H colorectal cancer) | - The observed 14% ORR is nearly three times the historical PD-(L)1 re-challenge response rate (≤5%), indicating significant disease control in resistant tumors[5] - Solnerstotug continues to demonstrate good tolerability, with only 4 cases (7%) of Grade 1 cytokine release syndrome (CRS) among 60 patients, all mild and manageable, and no dose-limiting toxicities observed[10] Clinical Progress and Outlook The dose expansion cohort has completed its target enrollment of 60 patients, with full data anticipated by the end of 2025, as the company focuses on completing ongoing patient studies and finalizing a robust Phase 2 strategy - The dose expansion cohort has reached its target enrollment (n=60)[10] - Full expansion data are expected to be released by the end of 2025[10] - The company is focused on completing the dose expansion study for patients currently under investigation and finalizing a robust Phase 2 strategy[3] Scientific and Clinical Visibility The company enhanced its scientific and clinical visibility in 2024 through various academic conferences and publications, notably a peer-reviewed paper in Nature Communications detailing solnerstotug's mechanism of action - Spatial proteomic analysis of VISTA and PSGL-1 across various tumor types was presented at the SITC 2024 conference[10] - A peer-reviewed research paper describing solnerstotug's mechanism of action, selectively targeting the active form of VISTA within the tumor microenvironment, was published in Nature Communications in April 2024[10] Corporate Updates The company underwent organizational restructuring in Q4 2024 to streamline operations and made key leadership appointments Organizational Restructuring and Appointments In Q4 2024, the company underwent organizational restructuring to streamline operations and focus resources on solnerstotug's clinical advancement, alongside appointing new finance and accounting leadership and a part-time Chief Medical Officer - In the fourth quarter of 2024, the company implemented organizational restructuring to streamline operations and concentrate resources on solnerstotug's clinical development[10] - Josiah Craver was appointed Senior Vice President of Finance, subsequently assuming the role of Chief Financial and Accounting Officer[10] - Ron Weitzman, M.D., F.A.C.P., was appointed as part-time Chief Medical Officer[10] Year End 2024 Financial Results The company reported a reduced net loss for 2024, with sufficient cash reserves to fund operations into the second quarter of 2026 Financial Highlights As of December 31, 2024, the company held $41.3 million in cash, cash equivalents, and marketable securities, projected to fund operations into Q2 2026, with R&D expenses at $18.6 million (flat year-over-year) and G&A expenses at $13.0 million (decreased year-over-year), resulting in a full-year net loss of $30.2 million, a reduction from the prior year 2024 Financial Performance Overview (Compared to 2023) | Financial Metric | December 31, 2024 (Millions USD) | December 31, 2023 (Millions USD) | Change (Millions USD) | | :--- | :--- | :--- | :--- | | Cash, Cash Equivalents, and Marketable Securities | $41.3 | $65.8 | Decrease $24.5 | | Research & Development (R&D) Expenses | $18.6 | $18.3 | Increase $0.3 | | General & Administrative (G&A) Expenses | $13.0 | $18.8 | Decrease $5.8 | | Net Loss | $30.2 | $34.1 | Decrease $3.9 | - The company projects its current cash balance is sufficient to support operations into the second quarter of 2026[7] Financial Statements The financial statements detail a reduced net loss and decreased operating expenses for 2024, alongside changes in assets and liabilities Condensed Statements of Operations For fiscal year 2024, total operating expenses decreased to $32.614 million from $37.064 million in 2023, with net loss narrowing from $34.101 million in 2023 to $30.157 million in 2024, and net loss per share decreasing from $1.22 to $1.20 Condensed Statements of Operations (Amounts in thousands, except per share data) | | 2024 | 2023 | | :--- | :--- | :--- | | Operating Expenses: | | | | Research & Development Expenses | $18,627 | $18,299 | | General & Administrative Expenses | $13,036 | $18,765 | | Impairment of long-lived assets | $951 | $— | | Total Operating Expenses | $32,614 | $37,064 | | Operating Loss | ($32,614) | ($37,064) | | Total other income | $2,457 | $2,963 | | Net Loss | ($30,157) | ($34,101) | | Net Loss Per Share (Basic and Diluted) | ($1.20) | ($1.22) | Selected Condensed Balance Sheet Data As of December 31, 2024, total assets were $45.361 million, total liabilities were $6.975 million, and total stockholders' equity was $38.386 million, with both total assets and stockholders' equity decreasing compared to year-end 2023 Selected Condensed Balance Sheet Data (Amounts in thousands) | | December 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $9,994 | $13,011 | | Marketable securities | $31,341 | $52,746 | | Total assets | $45,361 | $74,374 | | Total liabilities | $6,975 | $9,479 | | Total stockholders' equity | $38,386 | $64,895 | Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements involving risks and uncertainties regarding product candidate development, potential therapeutic benefits, clinical trial timing, and cash flow projections, where actual results may differ materially from expectations - This press release contains forward-looking statements involving risks and uncertainties regarding product candidate development, potential therapeutic benefits, clinical trial timing, and cash flow projections. Actual results may differ materially from expectations[16]