Executive Summary

Q2 2025 was operationally constructive but financially mixed: non-GAAP EPS of $(2.88) missed S&P Global consensus of $(2.50), driven primarily by $10.0M of in‑process R&D, while G&A declined materially year over year . EPS consensus from S&P Global marked with * below; values retrieved from S&P Global.
Key catalysts advanced: U.S. IND for AXN‑2510/IMM2510 was cleared in July; U.S. trial initiation remains targeted before year-end 2025; ImmuneOnco will present updated monotherapy data in squamous NSCLC at WCLC (Sep 6–9, 2025) .
Early Phase 2 combo read-in from China showed partial responses in 62% of evaluable front‑line NSCLC patients (80% squamous; 46% non‑squamous) with a manageable safety profile and no DLTs, supporting further development .
Liquidity remains adequate with $103.6M in cash and investments at 6/30/25, and runway beyond 2026 reiterated; sequential cash usage largely reflects pipeline investment and in‑process R&D .

What Went Well and What Went Wrong

What Went Well

IND clearance and U.S. trial timing intact: “With the clearance of the U.S. IND, initiation of the U.S. clinical trial…anticipated before the end of 2025” .
Encouraging China combo data: partial responses in 62% of evaluable 1L NSCLC patients (80% in squamous; 46% in non‑squamous) with no DLTs and low discontinuations, supporting best‑in‑class potential for the PD‑(L)1xVEGF class .
Cost discipline in G&A: G&A fell to $6.16M from $10.71M YoY, reflecting ongoing operating efficiency .

What Went Wrong

EPS miss vs consensus: Primary (S&P) EPS of $(2.88) vs $(2.50)* was a miss, largely due to $10.0M in‑process R&D and higher R&D spend QoQ .
Higher operating loss YoY: Total operating expenses rose to $23.44M from $14.14M YoY driven by in‑process R&D and increased R&D .
Cash draw: Total cash and investments declined to $103.6M from $111.8M in Q1 and $115.1M at YE’24 as pipeline investment accelerated .

Financial Results

Year-over-Year (Q2 2025 vs Q2 2024)

Metric ($USD Millions, except per-share)	Q2 2024	Q2 2025
In-Process R&D	$0.00	$10.00
R&D Expense	$2.92	$6.74
G&A Expense	$10.71	$6.16
Restructuring & Impairment	$0.51	$0.54
Total Operating Expenses	$14.14	$23.44
Net Loss	$14.92	$21.39
GAAP EPS (Basic & Diluted)	$(2.29)	$(3.24)
Non-GAAP EPS	$(1.57)	$(2.88)

Sequential (Q2 2025 vs Q1 2025)

Metric ($USD Millions, except per-share)	Q1 2025	Q2 2025
R&D Expense	$5.37	$6.74
G&A Expense	$9.11	$6.16
Restructuring & Impairment	$16.08	$0.54
Total Operating Expenses	$30.56	$23.44
Net Loss	$28.20	$21.39
GAAP EPS (Basic & Diluted)	$(4.32)	$(3.24)
Non-GAAP EPS	$(1.32)	$(2.88)

Cash & Investments (Trend)

Metric ($USD Millions)	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025
Cash, Cash Equivalents, Restricted Cash, Marketable Securities & LT Investments	$115.15	$111.80	$103.63

Notes:

Company remains pre-revenue; no revenue was disclosed in the operating results. S&P Global revenue consensus for Q2 2025 was $0.00* with 4 estimates. Values with * retrieved from S&P Global.
Other items: Interest income $1.04M; interest expense $(1.58)M; other rental income $2.24M in Q2 2025 .

Clinical KPIs (Partner-Reported, China)

KPI	Q2 2025 Update
1L NSCLC Combo (chemo + ‘2510), efficacy evaluable (n=21 of 33 dosed)	Partial responses in 62% overall; 80% (8/10) squamous; 46% (5/11) non‑squamous
Safety (n=33 safety evaluable)	No DLTs; no TRAE leading to dose reduction or death; one TRAE leading to discontinuation; Grade 3+ TRAEs mostly hematologic; AEs typical of VEGF or immune‑related were uncommon/low‑grade

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
U.S. Trial Initiation for AXN‑2510/IMM2510	2025	Anticipated before end of 2025, subject to approvals	IND cleared; initiation anticipated before end of 2025	Maintained timeline; regulatory milestone achieved
Clinical Data Disclosure (Monotherapy, squamous NSCLC)	Sep 2025	ImmuneOnco anticipated 2H 2025 data disclosures	WCLC poster accepted for updated monotherapy data Sep 6–9, 2025	Converted expectation into scheduled conference update
Cash Runway	Multi‑year	Runway beyond 2026	Runway beyond 2026 reiterated	Maintained

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was located in company filings/IR materials; themes below are drawn from Q4’24/Q1’25/Q2’25 press releases.

Topic	Previous Mentions (Q4 2024, Q1 2025)	Current Period (Q2 2025)	Trend
U.S. Regulatory Progress	U.S. 1L NSCLC combo trial anticipated before YE25, pending approvals	U.S. IND for AXN‑2510 cleared; initiation still targeted before YE25	Advancing
China Clinical Execution (ImmuneOnco)	Phase 1b/2 combo in NSCLC initiated; monotherapy data anticipated in 1H/2H 2025	Preliminary 1L combo data shared (62% PR rate overall); WCLC monotherapy poster accepted	Advancing
Spend Mix (R&D vs G&A)	R&D ramp began in Q1; G&A trending lower YoY	R&D up QoQ; G&A down YoY; in‑process R&D of $10M lifted OpEx	R&D up; G&A down
Leadership/Board	No major changes in Q4’24; narrative focus on registrational strategy	New CMO (June); Dr. Maraganore added to subsidiary board (June)	Strengthening team
Capital Runway	Beyond 2026	Beyond 2026 reaffirmed	Stable

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. We look forward… to the initiation of our previously announced US phase 1 clinical trial before the end of this year.” — Bronson Crouch, CEO .
“We are pleased to announce the clearance of the ‘2510 IND by the FDA. Evaluating ‘2510 in a global population will be a critical milestone in the clinical development of ‘2510.” — Jamie Freedman, M.D., Ph.D., CMO .
“John’s appointment reflects our commitment to assembling world-class leadership to maximize the value of the ‘2510 program for patients and shareholders…” — Bronson Crouch, CEO (on Dr. Maraganore) .

Q&A Highlights

No Q2 2025 earnings call transcript was available; analysis relies on the company’s 8‑K/press releases and partner disclosures .

Estimates Context

Metric	Q2 2025 Consensus*	Q2 2025 Actual	Delta
Primary EPS (S&P definition)	$(2.50)*	$(2.88)	−$0.38 (miss)
Primary EPS – # of Estimates	4*	—	—
Revenue	$0.00*	Not disclosed (pre‑revenue)	—
Revenue – # of Estimates	4*	—	—

*Values retrieved from S&P Global.

Implications: Street likely revises near-term non‑GAAP EPS slightly lower to reflect in‑process R&D and continued R&D ramp; revenue models remain at zero pending commercialization.

Key Takeaways for Investors

The development narrative strengthened: U.S. IND clearance and WCLC monotherapy update provide visible catalysts into 2H25 and early 2026 .
Early combo efficacy in China (62% PR; 80% in squamous) with clean safety de‑risks mechanism and supports potential best‑in‑class positioning for PD‑(L)1xVEGF in 1L NSCLC .
Non‑GAAP EPS miss reflects accelerated investment (in‑process R&D $10M) rather than structural cost creep; G&A continues to trend down YoY .
Liquidity appears sufficient (runway beyond 2026), but continued clinical execution is key to preserving negotiating leverage and avoiding dilutive raises .
Near-term stock drivers: WCLC poster details and U.S. trial initiation timing; any additional partner-led data readouts could be catalysts .
Medium-term thesis hinges on confirming efficacy magnitude/durability and safety in global settings; watch class competitors and comparative data highlighted in prior corporate materials .
Risk factors include reliance on China-generated data for ex‑China development, macro U.S.-China tensions, and typical clinical/regulatory uncertainties .

Source Notes

Q2 2025 8‑K/press release: financials, cash, and corporate update .
Q1 2025 8‑K/press release: prior trends and guidance baselines .
Q4 2024 8‑K/press release: baseline financials and strategy context .
China Phase 2 combo preliminary data: ImmuneOnco announcement referenced by Instil .
IND clearance press release (July 2, 2025) .
Leadership updates (June 2025) .

Instil Bio, Inc. (TIL)·Q2 2025 Earnings Summary