sensei(SNSE) - 2025 Q2 - Quarterly Results

Corporate and Clinical Program Highlights Sensei Biotherapeutics updated on solnerstotug's Phase 1/2 data expected by year-end 2025 and corporate events CEO Commentary and Strategy The CEO outlined solnerstotug's strategic shift, emphasizing its safety profile and potential in the PD-(L)1 resistant market - Solnerstotug, in combination with cemiplimab, has demonstrated a favorable safety profile with no significant additional toxicity compared to PD-(L)1 monotherapy[3] - The company envisions multiple Phase 2 studies for solnerstotug in PD-(L)1 resistant tumor types to target high-value segments of the ~$50 billion PD-(L)1 market[3] - The final Phase 2 strategy will be strongly influenced by the full dose expansion dataset planned for presentation later in 2025[3] Solnerstotug Clinical Program Update The Phase 1/2 solnerstotug trial completed enrollment with 64 patients; full data expected by year-end 2025 - Full dose expansion data, including 6-month progression-free survival (PFS), from the Phase 1/2 study is expected by year-end 2025[5] Phase 1/2 Dose Expansion Cohort Enrollment | Arm | Patient Group | Number of Patients | | :--- | :--- | :--- | | Monotherapy | "Cold" MSS CRC | 10 | | Combination (with cemiplimab) | "Cold" MSS CRC | 10 | | Combination (with cemiplimab) | "Hot" Tumors (41/44 PD-(L)1 resistant) | 44 | | Total | | 64 | Other Corporate Updates Sensei announced favorable clinical data, an ESMO presentation, and regained Nasdaq compliance post-split - Clinical data from the dose expansion cohort will be presented at the European Society for Medical Oncology (ESMO) Congress in October 2025[11] - The company regained Nasdaq compliance after executing a 1-for-20 reverse stock split of its common stock, effective June 16th[11] - On March 27th, Sensei announced favorable preliminary clinical data from the dose expansion stage, demonstrating positive activity in patients with PD-(L)1 resistant "hot" tumors[11] Second Quarter 2025 Financial Results Sensei Biotherapeutics reported $28.6 million cash for Q2 2025, with reduced expenses and a $4.9 million net loss Financial Performance Summary Cash position was $28.6 million as of June 30, 2025, with reduced expenses and a $4.9 million net loss - Cash, cash equivalents, and marketable securities totaled $28.6 million as of June 30, 2025, which is expected to fund operations into the second quarter of 2026[7] Q2 2025 vs. Q2 2024 Operating Results (in millions) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | R&D Expenses | $2.5 million | $4.6 million | | G&A Expenses | $2.7 million | $3.2 million | | Net Loss | $4.9 million | $7.1 million | Condensed Financial Statements Unaudited Q2 2025 statements show $5.2 million operating expenses, $4.9 million net loss, and $31.8 million total assets Condensed Statements of Operations (Unaudited, in thousands) | | Three Months Ended June 30, | | | :--- | :--- | :--- | | | 2025 | 2024 | | Research and development | $2,533 | $4,584 | | General and administrative | $2,673 | $3,203 | | Total operating expenses | $5,206 | $7,787 | | Net loss | $(4,936) | $(7,142) | | Net loss per share, basic and diluted | $(3.91) | $(5.69) | Selected Condensed Balance Sheet Data (Unaudited, in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $12,557 | $9,994 | | Marketable securities | $16,071 | $31,341 | | Total assets | $31,783 | $45,361 | | Total stockholders' equity | $27,314 | $38,386 | Forward-Looking Statements This section outlines forward-looking statements on product development, clinical trials, and financial runway, subject to risks - Statements regarding product development, clinical trial timing for solnerstotug, and the company's cash runway are forward-looking and based on current expectations[15] - Key risks include the potential for product candidates not to be successfully developed or commercialized, delays in clinical trials, and prior results not being replicated in future studies[16] - The company refers to its Quarterly Report on Form 10-Q and other SEC filings for a more detailed description of risks and uncertainties[16]