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Instil Bio, Inc. (TIL)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered zero revenue and a narrowed GAAP net loss per share of $2.01 vs $3.24 in Q2 and $3.54 YoY; non-GAAP EPS was $1.75 loss, reflecting lower stock-based comp and no restructuring in the quarter .
  • Consensus non-GAAP EPS was better-than-feared: Primary EPS Consensus Mean at -$2.355 vs actual -$1.75, a beat of $0.61; revenue consensus stood at $0 in Q1–Q3 2025, consistent with no reported revenue in company results (values from S&P Global)*.
  • Liquidity remains solid with $83.4M in cash, equivalents, restricted cash, marketable securities, and long-term investments; management reiterated runway to fund the operating plan beyond 2026 .
  • Clinical execution advanced: first US patient dosed in the Phase 1 monotherapy trial in October; updated monotherapy data in squamous NSCLC presented at WCLC in September; preliminary combo chemo data in 1L NSCLC indicated encouraging partial response rates (external collaborator trial) .

What Went Well and What Went Wrong

What Went Well

  • Non-GAAP loss per share improved to -$1.75 vs -$2.88 in Q2 and -$2.55 YoY; GAAP EPS also improved sequentially to -$2.01 from -$3.24, aided by lower G&A and no restructuring in Q3 .
  • Clinical progress: “We are pleased with the preliminary clinical results of the combination of ‘2510 with chemotherapy in patients with front-line NSCLC,” said CEO Bronson Crouch, highlighting potential best-in-class efficacy for the PD-(L)1xVEGF bispecific class .
  • Regulatory/clinical milestone: “Evaluating ‘2510 in a global population will be a critical milestone,” said CMO Jamie Freedman, following US IND clearance and Phase 1 monotherapy first-patient dosing in October .

What Went Wrong

  • No commercial revenue; operating losses continue given R&D and G&A intensity; Q3 total operating expenses were $15.0M and loss from operations was -$15.0M (matches zero revenue) .
  • Ongoing dependency on collaborator-generated clinical data in China and related regulatory uncertainties explicitly noted in forward-looking statements (reliance on third parties, potential inability to rely on China trial data ex-China) .
  • Macro headwinds cited: risks from interest rates, inflation, tariffs, and US–China trade/political tensions that could adversely affect operations and collaborator activities .

Financial Results

Income Statement and EPS (Quarterly)

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$0.0 $0.0 $0.0 $0.0
Total Operating Expenses ($USD Millions)$23.6 $30.6 $23.4 $15.0
Loss from Operations ($USD Millions)$(23.6) $(30.6) $(23.4) $(15.0)
Interest Income ($USD Millions)$1.65 $1.18 $1.04 $0.89
Interest Expense ($USD Millions)$(2.01) $(1.10) $(1.58) $(1.58)
Other Rental Income ($USD Millions)$1.49 $2.24 $2.24 $2.24
Other (Expense) Income, net ($USD Millions)$(0.53) $0.04 $0.34 $(0.12)
Net Loss ($USD Millions)$(23.0) $(28.2) $(21.4) $(13.6)
GAAP EPS ($)$(3.54) $(4.32) $(3.24) $(2.01)
Non-GAAP EPS ($)$(2.55) $(1.32) $(2.88) $(1.75)
Weighted Avg Shares (Millions)6.51 6.53 6.60 6.76

Notes: Revenue is implied zero as Loss from Operations equals -Total Operating Expenses each quarter .

Operating Expense Mix (Quarterly)

MetricQ3 2024Q1 2025Q2 2025Q3 2025
In-process R&D ($USD Millions)$10.0 — $10.0 —
R&D Expense ($USD Millions)$0.56 $5.37 $6.74 $9.13
G&A Expense ($USD Millions)$10.71 $9.11 $6.16 $5.90
Restructuring & Impairment ($USD Millions)$2.36 $16.08 $0.54 —
Total OpEx ($USD Millions)$23.63 $30.56 $23.44 $15.02

Balance Sheet Snapshot

MetricQ1 2025 (Mar 31)Q2 2025 (Jun 30)Q3 2025 (Sep 30)
Cash, Equivalents, Restricted, Marketable Securities & LT Investments ($USD Millions)$111.8 $103.6 $83.4
Total Assets ($USD Millions)$237.4 $231.0 $211.8
Total Liabilities ($USD Millions)$92.5 $99.3 $91.3
Stockholders’ Equity ($USD Millions)$144.9 $131.7 $120.4

Segment breakdown: Not applicable (no commercial segments disclosed) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti-yearFund operating plan beyond 2026 (Q1, Q2 guidance) Fund operating plan beyond 2026 reiterated (Q3) Maintained
US Phase 1 Monotherapy (‘2510)2025Initiation before end of 2025 (post-IND clearance, July) First patient dosed in Oct 2025 Achieved
WCLC Monotherapy Update (China)Sep 2025Abstract accepted; updated data to be presented Updated data presented in September Achieved
US Combo Chemo Trial in 1L NSCLC2025Anticipated to commence before end of 2025, subject to approvals (Q1) No explicit Q3 update beyond continued focus on monotherapy trial Maintained/Unconfirmed timing

Earnings Call Themes & Trends

No Q3 2025 earnings call transcript was found in the document catalog; the company furnished the 8-K and press release without an accompanying call transcript for the period [ListDocuments, 0 results].

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
Product Performance (‘2510)Early combo chemo data in 1L NSCLC: PRs indicated partial responses and strong early signal (Q2 Jul 31) Updated squamous NSCLC monotherapy data presented at WCLC; first US monotherapy patient dosed Positive momentum; advancing into broader clinical programs
Regulatory/INDUS IND cleared for ‘2510 in July (Q2) Transition from IND to active US dosing in Oct Execution progress
R&D ExecutionR&D spend rising from Q1 to Q3; restructuring heavy in Q1 R&D higher; no restructuring in Q3 Reallocation from restructuring to development
Macro/US–China TensionsCited as a risk in FLS (Q1/Q2) Reiterated in Q3 FLS Ongoing risk backdrop
Collaborator Reliance (ImmuneOnco)Trials and data generation in China; reliance risks noted Continued reliance; WCLC update; combination trial data progressing Persistent strategic dependency

Management Commentary

  • “We are pleased with the preliminary clinical results of the combination of ‘2510 with chemotherapy in patients with front-line NSCLC, which suggest the potential for best-in-class efficacy in the promising PD-(L)1xVEGF bispecific antibody class.” — Bronson Crouch, CEO .
  • “Evaluating ‘2510 in a global population will be a critical milestone in the clinical development of ‘2510.” — Jamie Freedman, M.D., Ph.D., CMO .
  • “‘2510 has demonstrated early but compelling activity in front-line NSCLC patients… the PD-(L)1xVEGF bispecific class has the potential to become the new standard of care for front-line NSCLC.” — Prof. Caicun Zhou, Lead Investigator (China) .
  • “This data paves the way for its advancement into Phase 3 clinical studies…” — Dr. Tian Wenzhi, CEO of ImmuneOnco .

Q&A Highlights

No Q3 2025 earnings call transcript was available; therefore, no Q&A themes or clarifications can be extracted for this quarter [ListDocuments, 0 results].

Estimates Context

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Primary EPS Consensus Mean ($)-2.1075*-2.5875*-2.5025*-2.355*
Actual Primary EPS ($)-2.55 -1.32 -2.88 -1.75
Beat/(Miss) ($)-0.44*+1.27*-0.38*+0.61*
# of EPS Estimates4*4*4*4*
Revenue Consensus Mean ($USD)Q3 2024Q1 2025Q2 2025Q3 2025
Consensus950,000*0*0*0*
ActualN/A$0 $0 $0

Values retrieved from S&P Global.*

Implications: The non-GAAP EPS beat in Q3 may prompt modest upward revisions to near-term loss per share forecasts, while revenue remains de minimis given the company’s pre-commercial status (no change to revenue expectations).

Key Takeaways for Investors

  • Clinical execution is the primary driver: US Phase 1 monotherapy trial is underway (first patient dosed), and updated monotherapy data were presented at WCLC; combo chemo data in 1L NSCLC remain encouraging and a potential future catalyst .
  • Liquidity is adequate for multi-year development with $83.4M in total cash and investments and runway beyond 2026, reducing near-term financing overhang vs typical development-stage peers .
  • Earnings optics improved: sequentially narrower GAAP and non-GAAP losses; operating expense profile shifting toward R&D while G&A and restructuring have declined .
  • Estimates context: non-GAAP EPS outperformed consensus in Q3; given zero revenue, estimate changes are likely confined to loss per share assumptions and opex cadence (values from S&P Global)*.
  • Risk factors are non-trivial: reliance on collaborator-generated data (China), uncertain data portability ex-China, and macro/trade tensions cited across filings; investors should discount timelines accordingly .
  • Near-term trading catalysts: additional ‘2510 data disclosures (monotherapy and combo), US site activations/enrollment pace, and any regulatory interactions; watch for clarity on US combo chemo trial timing in 1L NSCLC .
  • Medium-term thesis: positioning in the PD-(L)1xVEGF bispecific class with differentiated VEGF trap and ADCC features; proof-of-concept strength vs safety/PK/PD in global settings will shape the probability of success and partner interest .