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Sana Biotechnology, Inc. (SANA)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was mixed: non-GAAP EPS improved and beat consensus, but GAAP results were impacted by a $44.6M impairment tied to the suspension of internal manufacturing build-out and a shift to CDMOs .
  • Non-GAAP EPS of $0.16 loss beat Wall Street consensus ($0.20 loss), while GAAP EPS widened year over year due to impairment; cash ended the quarter at $72.7M, with pro forma cash of $177.2M after July–August financings, extending the runway into 2H 2026 .
  • Clinical catalysts strengthened: 6‑month UP421 data and NEJM publication validated immune evasion and islet function without immunosuppression; FDA INTERACT feedback increased confidence toward an SC451 IND as early as 2026 .
  • Capital actions totaled ~$105M since quarter end (ATM + offering), a key stock reaction catalyst; strategic pivot to CDMOs reduces near-term capex and risk but raises questions on long-term manufacturing control .

What Went Well and What Went Wrong

What Went Well

  • Positive clinical momentum: “We are positioned to deliver on our goal of a broadly accessible single treatment with no immunosuppression leading to long-term normal blood glucose without exogenous insulin in patients with type 1 diabetes” .
  • Strengthened balance sheet: “We have raised over $100 million in new capital since the end of the second quarter, strengthening our balance sheet and allowing us to continue to invest appropriately in moving our pipeline forward” .
  • Regulatory confidence: FDA INTERACT feedback increases confidence in HIP-edited GMP master cell bank and non-clinical plan for SC451; IND targeted as early as 2026 .

What Went Wrong

  • Impairment hit GAAP results: $44.6M non-cash impairment on Bothell and Seattle facilities as internal manufacturing build-out was suspended; GAAP net loss widened to $93.8M .
  • Cash decline before financings: Quarter-end cash was $72.7M vs $152.5M at YE 2024, driven primarily by cash used in operations ($81.8M) .
  • Organizational and liability headwinds: Resignation of SVP and Head of Hypoimmune Platform and increases in success payment liabilities/contingent consideration contributed to volatility and investor concern .

Financial Results

EPS vs Prior Periods and Year

MetricQ2 2024Q1 2025Q2 2025
GAAP Net Loss per Share ($)(0.21) (0.21) (0.39)
Non-GAAP Net Loss per Share ($)(0.32) (0.20) (0.16)

Operating Expenses, Net Loss, and Cash

Metric ($USD Millions)Q4 2024Q1 2025Q2 2025
Cash, Cash Equivalents & Marketable Securities (period-end)152.5 104.7 72.7
Research & Development Expense47.0 37.2 29.8
General & Administrative Expense17.3 11.5 10.3
Impairment of Long-Lived Assets1.9 0.0 44.6
GAAP Net Loss49.1 49.4 93.8
Non-GAAP Operating Cash Burn (YTD)—46.6 (Q1 only) 79.0 (H1)

Estimates vs Actual (S&P Global)

MetricQ1 2025Q2 2025Q3 2025
Primary EPS Consensus Mean ($)(0.236)*(0.20088)*(0.18448)*
Primary EPS Actual ($)(0.20)*(0.16)*(0.15)*
Revenue Consensus Mean ($)0.00*0.00*0.00*

Values retrieved from S&P Global.

  • Q2 2025 EPS: beat by ~$0.04 vs consensus (non-GAAP actual (0.16) vs (0.20088) estimate).
  • Revenue: in line with zero expectations.

KPIs (Balance Sheet and Liabilities)

Metric ($USD Millions)Q4 2024Q1 2025Q2 2025
Total Assets501.0 —361.6
Contingent Consideration109.0 —117.1
Success Payment Liabilities4.6 —8.6
Total Liabilities250.5 —239.1
Total Stockholders’ Equity250.5 —122.6
Pro Forma Cash (post July–Aug financings)——177.2

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough 2026Into 2026 Into 2H 2026 Raised/extended
SC451 (T1D) IND TimingAs early as 2026As early as 2026 As early as 2026 Maintained
SG299 (in vivo CAR T) IND TimingAs early as 2026As early as 2026 As early as 2026 Maintained
Manufacturing StrategyNear-term approachInternal build-out in progress Suspend internal build-out; use CDMOs at present Lowered internal; shifted to CDMOs
Revenue/MarginsFY/QtrNo formal guidanceNo formal guidanceMaintained

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript found. Themes tracked across Q4 2024 (Q-2), Q1 2025 (Q-1), and Q2 2025 (current) from press releases and investor conferences.

TopicQ4 2024 (Q-2)Q1 2025 (Q-1)Q2 2025 (Current)Trend
Type 1 Diabetes Program (UP421/SC451)Preliminary 12-week UP421 results; SC451 preclinical durability (15-month mouse) 12-week UP421 clinical data; master cell bank foundation progress 6-month UP421 data; NEJM publication; FDA INTERACT feedback; SC451 IND as early as 2026 Strengthening clinical/regulatory confidence
Capital Markets/Runway$199M cash (Q3 2024); runway into 2026 $104.7M cash; runway into 2026; ATM program initiated ~$105M raised post quarter; runway into 2H 2026 Improved runway; frequent capital access
Manufacturing StrategyFacility investments (Bothell) —Suspend internal build-out; pivot to CDMOs Shift to outsourced capacity; de-risk capex
Allogeneic CAR T (SC291/SC262)Enrollment ongoing; data expected 2024/2025 Enrollment ongoing; autoimmune and oncology indications Enrollment ongoing; data expected 2025 Ongoing, data pending
In vivo CAR T (SG299)Preclinical NHP data; IND as early as 2026 NHP deep B cell depletion; IND as early as 2026 IND as early as 2026; strategy options discussed at MS conference Preclinical strong; capital path under evaluation
Regulatory/LegalAnticipated IND prep; risk-factor transparency —FDA INTERACT feedback improves confidence Constructive engagement
Macro/Tariffs/Supply Chain——Tariffs add cost; aim for US-proximal manufacturing end-stage; focus on FDA path Monitoring; manageable

Management Commentary

  • “We expect to file the IND for SC451 as early as next year... We have raised over $100 million in new capital since the end of the second quarter, strengthening our balance sheet...” — Steve Harr, President & CEO .
  • “Results... demonstrate the survival and function of pancreatic beta cells... with no immunosuppression... no safety issues, and the HIP-modified islet cells evaded immune detection.” .
  • “We need more money... we will focus what we need to to get type 1 diabetes across the goal line” — Steve Harr at Morgan Stanley Global Healthcare Conference .
  • IND gating: “Complete GLP tox and efficacy with representative material and transition to GMP manufacturing; initial clinical design will closely replicate the Swedish study” .

Q&A Highlights

  • IND path and trial design: Management reiterated two tracks (non-clinical package with representative material and GMP manufacturing), with initial clinical design mirroring Swedish UP421 experience to minimize variables .
  • Durability/readouts: Viability measured via C‑peptide dynamics, insulin independence, and PET‑MRI in sub-studies; aim for long-term durability, recognizing practical and economic constraints of frequent re-dosing .
  • Competitive landscape: Emphasis on unique immunosuppression‑free approach, O‑negative universal donor line, and urgency to maintain lead vs peers (e.g., Vertex) .
  • Capital allocation: Clear prioritization of T1D; options for SG299 include partnering or spin‑out; acknowledgment of capital intensity and need for further funding .

Estimates Context

  • Q2 2025 non-GAAP EPS beat consensus by ~$0.04; revenue in line at $0.
  • Consensus trends show improving EPS trajectory from Q1 to Q3 2025.
MetricQ1 2025Q2 2025Q3 2025
Primary EPS Consensus Mean ($)(0.236)*(0.20088)*(0.18448)*
Primary EPS Actual ($)(0.20)*(0.16)*(0.15)*
Revenue Consensus Mean ($)0.00*0.00*0.00*

Values retrieved from S&P Global.

Key Takeaways for Investors

  • Clinical validation in T1D continues to de‑risk SC451; NEJM publication and 6‑month data are incremental credibility drivers, a positive narrative catalyst .
  • EPS beat was driven by cost discipline and exclusion of non-cash items; GAAP optics remain pressured by impairment and valuation changes, which could introduce volatility .
  • Strategic pivot to CDMOs reduces near-term capex and execution risk; watch for CDMO capacity, quality, and cost dynamics as the T1D program scales .
  • Balance sheet strengthened post quarter with ~$105M raised; runway now into 2H 2026, but management explicitly flagged the need for additional capital or partnerships to fund broader ambitions (SG299) .
  • Near-term catalysts: 2025 data from SC291 and SC262, continued UP421 follow-ups, and SC451 IND preparation milestones; consider positioning ahead of clinical readouts .
  • Medium-term thesis hinges on SC451 IND execution (non-clinical package and GMP readiness) and strategic monetization/partnering of SG299 to balance capital needs with platform opportunity .
  • No Q2 2025 earnings call transcript was available; investors should rely on press release disclosures and recent conference commentary for qualitative context –.

Sources

  • Q2 2025 8‑K and press release: financials, pipeline updates, impairment, cash, and runway – –.
  • Preliminary Q2 2025 8‑K (Aug 6): preliminary cash and impairment indication; personnel update .
  • Q1 2025 8‑K: prior quarter financials, ATM program .
  • Q4 2024 8‑K: prior year trend context –.
  • NEJM publication press release: clinical validation –.
  • Investor conference transcript: IND path, durability, competition, capital needs, tariffs/supply chain –.
  • Estimates (S&P Global): Primary EPS and Revenue consensus and actuals (see table; values retrieved from S&P Global).