Sana Biotechnology, Inc. (SANA)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 was execution-heavy with clinical and CMC progress; GAAP EPS improved to $0.21 loss vs $0.49 loss in Q1 2024, and management reiterated cash runway into 2026 .
• EPS beat consensus: S&P Global Q1 2025 EPS consensus was -$0.236*, and S&P-recorded actual EPS was -$0.200*, a beat driven by lower R&D and G&A vs last year; revenue remains pre-commercial at ~$0* (consensus $0*) .
• Guidance maintained on near-term clinical catalysts (GLEAM and VIVID data in 2025) and IND timing (SC451 and SG299 as early as 2026) ; financing flexibility enhanced via new $119.0M ATM program with TD Cowen .
• Near-term stock catalysts: six-month UP421 data in an ADA plenary on June 23 and continued 2025 readouts in autoimmune CAR-T and oncology; potential equity overhang from ATM capacity .

What Went Well and What Went Wrong

What Went Well

• Clinical signal in T1D strengthened: 12-week UP421 data showed persisted C‑peptide, meal-responsive insulin secretion, MRI evidence of graft survival, and no safety issues without immunosuppression. “We have made significant progress in 2025 toward a functional cure of this disease.”
• IND path clarity: Foundation for a genomically stable, gene‑modified master cell bank established; SC451 and SG299 INDs as early as 2026 .
• Expense discipline: R&D fell to $37.2M vs $56.4M YoY; G&A fell to $11.5M vs $16.3M YoY, improving GAAP EPS and non‑GAAP loss .

What Went Wrong

• Pre‑commercial profile persists: no product revenue yet; program value realization remains milestone-dependent and capital intensive .
• Portfolio selectivity and funding constraints: Management flagged that continuation of certain CAR‑T efforts (especially oncology) depends on investor/partner support; focus will not compromise diabetes asset .
• Equity overhang risk: Newly established ATM program up to $119.0M may pressure shares if utilized at unfavorable prices .

Financial Results

GAAP EPS vs Prior Periods

YoY: GAAP EPS improved by $0.28 (from -$0.49 to -$0.21) on lower R&D and G&A . QoQ: flat at -$0.21 .

Revenue (Pre-Commercial) and EPS vs Estimates (S&P Global)

Values retrieved from S&P Global.

Operating Expenses and Cash KPIs

Notes: Non‑GAAP definitions and reconciliations provided by the company .

Segment/Revenue Breakdown

• Not applicable; Sana is pre-revenue (no segment revenues disclosed) .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Type 1 diabetes (T1D) remains a large, unmet need… we have made significant progress in 2025 toward a functional cure.” — Steve Harr, President & CEO .
• “We recently presented 12‑week clinical data for UP421… continue to evade immune detection and function three months after transplant… broadly generalizable across the population.” .
• “This should work… transformative where patients reach our goal: normal blood glucose with no more insulin and no immunosuppression.” — Steve Harr at BofA Healthcare Conference .
• “We will not compromise the diabetes asset [given capital constraints].” — Steve Harr .

Q&A Highlights

• IND and CMC path: Four scientific challenges outlined; hypoimmune rejection overcome; differentiation scaled for Phase 1; genomically stable master cell bank established; pivotal-ready manufacturing process must be locked ahead of registration studies .
• Trial design sizing: Reference analog programs suggests total exposure on the order of ~50 patients; Sana’s program may be in a similar range, adjusted for broader patient population and lack of immunosuppression .
• Autoimmune CAR‑T (SC291): Objective is dose‑dependent deep B‑cell depletion with clinical benefit; outcome bands considered vs autologous CAR‑T (ok/good/great) to gauge convenience/efficacy tradeoffs .
• Capital allocation: Continuation of certain CAR‑T efforts depends on investor/partner validation; diabetes asset remains top priority .

Estimates Context

• Q1 2025: EPS beat vs consensus (S&P): -$0.200 actual* vs -$0.236 consensus*, driven by lower R&D and G&A; revenue remains $0* as pre-commercial .
• Potential estimate revisions: Continued cost discipline and clarity on clinical timelines could support incremental upward adjustments to outer‑quarter EPS expectations; however, funding cadence (ATM usage) and trial readouts will shape conviction.
  Values retrieved from S&P Global.

Key Takeaways for Investors

• T1D program is the engine: 12‑week human data without immunosuppression de‑risk core biology; six‑month ADA plenary is a near‑term sentiment catalyst .
• Capital flexibility improved: $119.0M ATM enables opportunistic financing ahead of INDs; monitor issuance pace/price for dilution risk .
• 2025 readouts are pivotal: GLEAM/VIVID data will inform allogeneic CAR‑T competitiveness vs autologous across efficacy/convenience dimensions .
• Execution focus on CMC/IND: Master cell bank stability and manufacturing process lock are critical to timeline; FDA interactions underway .
• Expense discipline matters: Material YoY reductions in R&D and G&A improved EPS and non‑GAAP burn; watch sustainability of lower spend as programs scale .
• Trade set-up: Near‑term upside on ADA and 2025 data flow; ATM could cap rallies if used aggressively; partner optionality for CAR‑T could mitigate capital needs .
• Risk monitors: Safety in higher doses/scaled stem cell products; durability in oncology; macro financing conditions for cell/gene therapy.

---

Earnings and operations data cited from company filings and press releases: Q1 2025 press release and financials ; Q4 2024 press release ; Q3 2024 press release ; ATM program 8‑K . Management commentary from BofA conference transcript .
S&P Global consensus/actual estimates marked with asterisks; Values retrieved from S&P Global.