Sensei Biotherapeutics, Inc. (SNSE)·Q4 2024 Earnings Summary

Executive Summary

• Sensei reported FY 2024 results alongside Q4 updates: FY net loss narrowed to $30.2M vs. $34.1M in 2023 as G&A fell materially; year-end cash, cash equivalents and marketable securities were $41.3M with runway into Q2 2026 .
• Clinical momentum is a focal catalyst: dose expansion in PD-(L)1–resistant “hot” tumors achieved target enrollment (n=60), with preliminary data showing 14% ORR and 62% DCR; full expansion data expected by YE25 .
• Q4 EPS was modestly better than S&P Global consensus; the company has no product revenue (consensus revenue $0) as a pre‑revenue biotech (see Estimates Context) [Values retrieved from S&P Global].
• Near-term stock catalysts: Q2 2025 data update from evaluable patients and Phase 2 strategy clarity; YE25 full expansion readout could reset efficacy expectations in PD-(L)1–resistant settings .

What Went Well and What Went Wrong

• What Went Well

  • Dose expansion enrollment achieved (n=60) with tolerable safety (no DLTs; mostly Grade 1–2 AEs; four cases of Grade 1 CRS out of 60) .
  • Early efficacy signal in PD-(L)1–resistant “hot” tumors: 14% ORR and 62% DCR; CR in MCC and PRs in MCC and MSI‑H CRC; all patients with shrinkage remain on treatment .
  • Cost discipline extended runway to Q2 2026; FY G&A dropped to $13.0M from $18.8M YoY, supporting a narrower FY net loss ($30.2M vs $34.1M) .

• What Went Wrong

  • Organizational restructuring in Q4 and closure of the Rockville research site; workforce reduced ~46% to concentrate resources on the clinic .
  • Non-cash long‑lived asset impairment ($0.95M) added to FY operating expenses .
  • No commercial revenue and continued operating losses; ongoing dependence on external financing conditions despite runway .

Financial Results

P&L summary (company-reported)

Revenue (pre-revenue biotech)

Cash and runway KPIs

EPS vs. S&P Global consensus (for estimate comparisons)

Notes: Asterisks denote values retrieved from S&P Global. S&P’s “Primary EPS” may be split-adjusted and not directly comparable to company-reported basic/diluted EPS in press releases; use primarily for estimate comparisons. [Values retrieved from S&P Global]

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “2024 was a pivotal year for Sensei … The responses we’ve observed in PD-(L)1 resistant tumors are highly encouraging … solnerstotug stands out for its encouraging response rates and favorable tolerability profile … We are now focused on completing dose expansion … and finalizing a robust Phase 2 strategy.” — John Celebi, President & CEO .
• On efficacy expectations: “Our next milestone is squarely focused on the efficacy component… Are we seeing tumor shrinkage? … and how long are these patients staying on study?” — John Celebi, Oppenheimer conf. .
• On conditional activity strategy: “We created an antibody that … only really binds to VISTA in its low pH form … allowing us to avoid binding … in the blood, but bind within tumors …” — John Celebi .
• On derisking vs prior VISTA efforts: “We’ve overcome the safety hurdles … in terms of safety [and] pharmacology … now we’re focused on activity.” — John Celebi .

Q&A Highlights

• Conditional activity as a strategic lever: Management framed pH‑selective binding as part of a next‑gen selectivity toolkit to improve pharmacology and safety relative to first‑generation anti‑VISTA programs .
• Efficacy endpoints and success bar: With small early cohorts, focus is on ORR/CR/PR evidence and duration on study in PD‑(L)1–experienced patients as a proxy for durability ahead of randomized PFS/OS studies .
• Enrollment mix and rationale: ~50/60 patients in dose expansion are “hot” tumors to maximize signal; a small MSS‑CRC monotherapy cohort serves as a mechanistic “science experiment” after a notable shrinkage case .
• Dose selection for Phase 2: Concentration on 3 and 15 mg/kg Q3W as likely Phase 2 doses following regulatory interactions and PK/safety confirmation .

Estimates Context

• As a pre‑revenue biotech, consensus revenue was $0 for Q2–Q4 and FY 2024; EPS came in modestly better than S&P Global consensus across Q2, Q3, Q4 and FY (see table below). The modest beats likely reflect sustained OpEx control (notably lower G&A) and recurring other income .
• S&P Global EPS methodology may be split‑adjusted and not directly comparable to company‑reported EPS; use for estimate comparisons only. [Values retrieved from S&P Global]

Note: Asterisks denote values retrieved from S&P Global.

Key Takeaways for Investors

• The dose‑expansion efficacy signal (14% ORR; 62% DCR in PD‑(L)1–resistant “hot” tumors) and tolerability provide early differentiation vs. prior anti‑VISTA efforts; YE25 full expansion readout is the major efficacy inflection point .
• Near‑term Q2 2025 update from evaluable patients can catalyze sentiment and inform Phase 2 dose/population (3 and 15 mg/kg Q3W), with durability/on‑treatment time closely watched .
• Cost actions and lower G&A underpin runway into Q2 2026, reducing financing overhang through Phase 1 completion, though the program remains dependent on capital markets thereafter .
• Absence of revenue and ongoing losses are expected; investor focus should remain on objective response durability and breadth across PD‑(L)1–resistant tumor types to support registrational paths .
• Watch for biomarker work (peripheral immunophenotyping, tumor genomics/transcriptomics) to refine enrichment strategies that could amplify response rates in Phase 2 .
• External visibility (peer‑reviewed MOA, major conference presence, investor webcasts) supports partner and investor engagement into key data milestones .

Appendix: Additional YoY Context (FY 2024 vs FY 2023)

Sources: Company press releases and 8‑K exhibits as cited above.