Sensei Biotherapeutics, Inc. (SNSE)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 delivered tightening P&L with net loss of $6.86M and diluted EPS of -$0.27, alongside total operating expenses down 17% YoY; cash, cash equivalents and marketable securities were $34.3M, with runway guided into Q2 2026 .
• Clinical narrative strengthened: dose expansion enrollment completed (n=63) and favorable preliminary activity in PD-(L)1‑resistant “hot” tumors (14% ORR, 62% DCR); full Phase 1/2 dose expansion data expected by year‑end 2025, informing a Phase 2 start targeted for Q1 2026, subject to financing .
• Against Wall Street consensus, EPS missed: S&P Global consensus EPS for Q1 2025 was -$4.47 vs actual -$5.40 on a split‑adjusted basis; revenue was in line at $0 given no product sales; note EPS figures reflect the June 1‑for‑20 reverse split . Values retrieved from S&P Global*.
• Near‑term stock catalysts: year‑end 2025 full data (efficacy/safety durability), Phase 2 design clarity, and financing visibility; reverse split (June 2025) aims to preserve Nasdaq listing and may influence trading dynamics .

What Went Well and What Went Wrong

What Went Well

• Dose expansion enrollment completed (63 patients) with favorable efficacy signals in PD-(L)1‑resistant “hot” tumors: 14% ORR and 62% DCR; durable CR in MCC, PRs in MCC and MSI‑H CRC; all patients with tumor shrinkage remained on treatment, suggesting potential durability .
• CEO tone constructive: “breakthrough quarter,” highlighting emerging potential for prolonged benefit in PD‑(L)1‑resistant patients and response rates “nearly three times higher than what would typically be expected” vs rechallenge .
• Safety profile remained favorable: no dose‑limiting toxicities; CRS cases were Grade 1 (7% of 60 patients), manageable; PK supports Q3W dosing .

What Went Wrong

• EPS missed consensus (split‑adjusted actual -$5.40 vs -$4.47) amid continued R&D and G&A spend and lower interest income; company remains pre‑revenue with ongoing net losses and no product sales*.
• Going concern language: management concluded substantial doubt beyond one year absent additional financing; Phase 2 timing is contingent on raising capital .
• No activity observed in MSS CRC (“cold” tumor) cohorts, consistent with historical checkpoint resistance, limiting near‑term breadth of efficacy across tumor types .

Financial Results

Income and EPS

Sequential takeaways: OpEx down QoQ vs Q3 2024; net loss narrowed. YoY: OpEx down 17% and net loss improved by ~$1.13M .

Balance Sheet Snapshot

KPIs (Clinical/Operational)

Estimates vs Actuals (S&P Global)

Note: Company‑reported diluted EPS was -$0.27 pre‑split; S&P values reflect the 1‑for‑20 reverse split on June 16, 2025 for comparability . Values retrieved from S&P Global*.

Guidance Changes

No revenue, margin, tax rate, or dividend guidance provided; focus remains on clinical and liquidity milestones .

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript found; themes drawn from 8‑K, press releases, and 10‑Q (no transcript listed) .

Management Commentary

• CEO (John Celebi): “This was a breakthrough quarter… response rates nearly three times higher than what would typically be expected… we’re laser‑focused on finalizing a Phase 2 strategy… guided by the full dataset we plan to present later this year” .
• CMO (Dr. Ron Weitzman): “The initial 14% response rate… nearly three times higher than what would typically be expected… we believe these early data suggest solnerstotug may provide a meaningful clinical benefit in select tumor types” .
• Investigator (Dr. Shiraj Sen): Responses “encouraging… continued clinical evaluation will be key in determining which patients are most likely to benefit” .

Q&A Highlights

• No formal Q1 2025 earnings call transcript available; company referenced a March 2025 webcast discussing preliminary dose expansion data and provided materials via 8‑K .
• Clarifications provided in filings: Phase 2 targeted for Q1 2026 subject to financing; enrollment complete and year‑end 2025 for full data; runway into Q2 2026 reaffirmed .
• Liquidity and going concern disclosures highlight the need for capital raises to sustain operations beyond one year from filing .

Estimates Context

• EPS: S&P Global consensus for Q1 2025 was -$4.47 vs actual -$5.40 (split‑adjusted), a miss of $0.93; company‑reported diluted EPS was -$0.27 pre‑split, consistent with split math (×20) . Values retrieved from S&P Global*.
• Revenue: Consensus $0.00; actual $0.00, in‑line with pre‑revenue status*.
• Coverage breadth: 3 EPS estimates and 3 revenue estimates for Q1 2025*.
• Implication: Street likely adjusts near‑term EPS trajectory modestly for financing costs/interest income and sustained R&D cadence; clinical outcomes remain the principal driver of estimate revisions*.

Key Takeaways for Investors

• Clinical momentum: Enrollment complete and favorable efficacy signals in PD‑(L)1‑resistant “hot” tumors (14% ORR, 62% DCR); durability and additional read‑outs by year‑end 2025 are the critical near‑term catalysts .
• Safety risk contained: No DLTs; Grade 1 CRS in 7% suggests tolerability advantage vs prior VISTA approaches, supporting combination with PD‑1 .
• Liquidity watch: Runway into Q2 2026 but going concern language underscores financing risk; Phase 2 start timing hinges on capital access .
• Valuation drivers: EPS miss was driven by operating structure and pre‑revenue status; stock likely more sensitive to clinical data and financing signals than near‑term P&L*.
• Execution milestones: Full dose expansion dataset (scope/biomarkers), Phase 2 design (indications/dose, cemiplimab strategy), and regulatory interactions (FDA dose guidance) will shape medium‑term thesis .
• Trading setup: Expect event‑driven volatility into year‑end data; reverse split may aid listing compliance but does not change fundamentals; liquidity headlines could amplify moves .
• Risk management: MSS CRC inactivity narrows initial addressable scope; open‑label design and maturing data introduce interpretation risk; financing terms could be dilutive .

---

References:

• Q1 2025 press release and 8‑K exhibit .
• Q1 2025 10‑Q financials, liquidity, and MD&A .
• Preliminary dose expansion 8‑K (Mar 27, 2025): efficacy, safety, PK, Phase 2 timing .
• Prior quarter (Q3 2024) press release .
• FY 2024 press release (Mar 28, 2025) .
• Reverse stock split press release (June 13, 2025) .

S&P Global disclaimer: Values retrieved from S&P Global*.