Instil Bio, Inc. (TIL)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 showed disciplined OpEx control (R&D down 26% YoY; G&A down 27% YoY) but elevated restructuring and impairment charges drove GAAP net loss per share to $4.32; non-GAAP EPS improved to $1.32 loss vs $2.39 loss in Q1 2024 .
• Cash, equivalents, restricted cash, marketable securities and long-term investments totaled $111.8M, with management reiterating runway beyond 2026 .
• Clinical execution advanced: China Phase 2 first-line NSCLC chemo-combo trial continued enrollment (>20 1L patients treated since late March), initial safety/efficacy readout expected in 2H 2025; U.S. plan pivoted to a monotherapy dose-optimization trial intended to bridge to China doses, aiming to accelerate a potential global Phase 3 in 1L NSCLC .
• Relative to S&P Global consensus, TIL delivered a significant EPS beat on “Primary EPS” (actual non-GAAP EPS -$1.32 vs -$2.59 consensus) while revenue remained at $0, in line with expectations*.

What Went Well and What Went Wrong

What Went Well

• Non-GAAP EPS improved year-over-year: -$1.32 vs -$2.39, driven by lower R&D and G&A despite higher restructuring and impairment charges .
• Clinical momentum: “We are delighted with the significant clinical advancements… we are confident that ‘2510 has the potential to emerge as a leading PD-(L)1xVEGF bispecific antibody” — Bronson Crouch, CEO .
• China Phase 2 1L NSCLC trial progressed with >30 NSCLC patients enrolled and >20 1L patients treated since end of March; initial safety/efficacy results guided for 2H 2025 .

What Went Wrong

• Restructuring and impairment charges rose sharply to $16.1M (vs $4.3M prior year), widening GAAP loss per share to -$4.32 .
• Balance sheet contraction quarter-over-quarter: total assets fell to $237.4M (from $263.6M in Q4), and stockholders’ equity decreased to $144.9M (from $169.4M) .
• Continued absence of revenue and dependence on collaborator-led China trial data heighten regulatory and geopolitical risks flagged in forward‑looking statements (e.g., U.S.–China tensions, tariffs, macro) .

Financial Results

P&L and OpEx Comparison (GAAP)

Notes: Non-GAAP excludes stock-based compensation and restructuring/impairment; see reconciliation in cited exhibits .

Balance Sheet Comparison

Estimates vs Actuals (Q1 2025)

Values retrieved from S&P Global*.
Note: Actual EPS in the press release refers to non-GAAP EPS; GAAP EPS was -$4.32 .

KPIs and Clinical Execution

Guidance Changes

Earnings Call Themes & Trends

Note: A Q1 2025 earnings call transcript was not available; content derived from 8‑K and press releases [ListDocuments result: none].

Management Commentary

• “We are delighted with the significant clinical advancements by our collaborator, ImmuneOnco, with ‘2510 for NSCLC in China… we are confident that ‘2510 has the potential to emerge as a leading PD‑(L)1xVEGF bispecific antibody” — Bronson Crouch, CEO .
• “Our collaboration on ‘2510 has achieved meaningful progress… We anticipate sharing further clinical data in the second half of 2025.” — Dr. Tian Wenzhi, CEO of ImmuneOnco .
• “We are thrilled to welcome Dr. Freedman as Chief Medical Officer… advancing AXN‑2510.” — Bronson Crouch, CEO .
• “This program has a strong scientific rationale, early signs of robust activity, and clear differentiation… As we approach the completion of enrollment… this summer” — Dr. John Maraganore .

Q&A Highlights

• No Q1 2025 earnings call transcript was available; no Q&A details to report (transcripts not found via document search and investor sources) [ListDocuments result: 0; SeekingAlpha indicates no transcripts available: “Transcripts are not available.” (reference)] .

Estimates Context

• EPS vs consensus (S&P Global): Primary EPS consensus -$2.5875 vs actual non‑GAAP -$1.32 — a material beat*, likely reflecting lower operating expenses and the use of non‑GAAP metrics excluding $16.1M restructuring/impairment and $3.5M stock-based comp .
• Revenue vs consensus: $0.00 consensus; actual $0.00 as Instil reported no revenue line items in Q1 2025 .
  Values retrieved from S&P Global*.

Key Takeaways for Investors

• Clinical timelines are intact or clarified: China Phase 2 1L NSCLC chemo‑combo enrollment continues with initial safety/efficacy readout in 2H 2025; U.S. pivot to monotherapy bridging may accelerate a global Phase 3 path in 1L NSCLC .
• Non‑GAAP EPS beat vs consensus underscores OpEx discipline, but GAAP loss widened on restructuring/impairment; stock moves will likely hinge on 2H 2025 data flow rather than near‑term financials .
• Cash runway beyond 2026 reduces near‑term financing risk amid data catalysts, though balance sheet contracted sequentially (assets and equity down) .
• Differentiation claims (VEGF trap, ADCC‑enhanced, PD‑L1 anchoring) and early monotherapy ORR (23% in R/R NSCLC; n=13) support a best‑in‑class narrative pending larger first‑line readouts .
• Geopolitical/regulatory overhang remains non‑trivial due to reliance on China clinical data and U.S.–China tensions; execution on U.S. IND/trial initiation in 2025 is an important de‑risking step .
• Near‑term trading setup: watch for mid‑year operational updates (enrollment completion Q3 2025, initial 2H 2025 safety/efficacy), and any U.S. regulatory milestones; estimate revisions likely modest until clinical data lands .
• Medium‑term thesis: If 1L NSCLC chemo‑combo data in China are compelling and U.S. bridging progresses, positioning for a global Phase 3 in mid‑2026 could drive multiple expansion tied to de‑risked development timelines .

Values retrieved from S&P Global*.