Executive Summary

Q3 revenue was $13.8M and diluted EPS was $(0.92); revenue modestly missed Wall Street consensus while EPS beat: Revenue actual $13.82M vs consensus $14.13M; EPS actual $(0.92) vs consensus $(1.00). Bold miss/beat: Revenue miss, EPS beat [*S&P Global].
FDA placed a clinical hold on Phase 3 MAGNITUDE and MAGNITUDE-2 trials of nex-z following a Grade 4 liver event; Intellia disclosed the dosed patient died on Nov 5, intensifying regulatory and safety overhangs .
Lonvo-z (NTLA-2002) execution remained strong: Phase 3 HAELO enrollment completed in Sept; pooled Phase 1/2 50mg data showed 97% attack-free and LTP-free status with up to three years’ follow-up; topline mid-2026 guidance maintained; BLA planned for 2H26, potential U.S. launch 1H27 .
Cash, cash equivalents and marketable securities were $669.9M; runway into mid-2027, buttressed by $114.5M ATM issuance in Q3 .
Stock reaction: shares fell ~42% on Oct 27 after the trial pause and later dropped ~23% on Nov 7 after the death disclosure, with further analyst downgrades; regulatory resolution and safety narrative are primary trading catalysts .

What Went Well and What Went Wrong

What Went Well

Lonvo-z durability and efficacy: pooled 50mg data showed deep kallikrein reductions (mean 89% at month 24) with 97% of patients attack-free and LTP-free; safety profile remained well-tolerated up to three years .
Phase 3 HAELO execution: enrollment completed in September 2025; company reaffirmed topline mid-2026, BLA 2H26, and U.S. commercial launch target in 1H27 .
Management tone on ATTR Phase 1 longer-term data: “It’s remarkable that even in patients with advanced heart failure… disease stabilization or improvement was observed out to 24 months” (John Leonard, M.D.) .

What Went Wrong

FDA clinical hold on MAGNITUDE/MAGNITUDE-2 after Grade 4 liver transaminase/bilirubin elevations; subsequent patient death intensified regulatory scrutiny and raised questions about commercial viability .
Milestone guidance for nex-z suspended pending regulatory alignment; uncertainty on timelines and risk mitigation plans weighs on estimates and investor confidence .
Q3 revenue modestly missed consensus, reflecting timing of collaboration reimbursements; while EPS beat on lower OpEx and other income, topline miss amid a safety hold challenges near-term sentiment [*S&P Global].

Financial Results

Metric	Q1 2025	Q2 2025	Q3 2025
Collaboration Revenue ($USD)	$16.63M	$14.25M	$13.82M
R&D Expense ($USD)	$108.4M	$97.0M	$94.7M
G&A Expense ($USD)	$29.0M	$27.2M	$30.5M
Net Loss ($USD)	$(114.3)M	$(101.3)M	$(101.3)M
Diluted EPS ($USD)	$(1.10)*	$(0.98)*	$(0.92)

Note: Asterisked EPS actuals for Q1/Q2 reflect SPGI values due to limited EPS disclosure in company press; Values retrieved from S&P Global.

Q3 vs Estimates (Wall Street Consensus):

Metric	Consensus	Actual	Result
Revenue ($USD)	$14.13M*	$13.82M	Miss
Primary EPS ($USD)	$(1.00)*	$(0.92)	Beat

Note: Values retrieved from S&P Global.

KPIs and Balance Sheet

KPI	Q1 2025	Q2 2025	Q3 2025
Cash & Equivalents+Marketable Securities ($USD)	$707.1M	$630.5M	$669.9M
Total Operating Expenses ($USD)	—	—	$125.3M
Operating Loss ($USD)	—	—	$(111.5)M
Other Income, net ($USD)	—	—	$10.2M
Weighted Avg Shares (Basic & Diluted)	—	—	110.2M
MAGNITUDE Enrollment (ATTR-CM)	—	—	>650 patients
MAGNITUDE-2 Enrollment (ATTRv-PN)	—	—	47 patients
HAELO Enrollment (lonvo-z)	—	Completed Sept 2025	Completed

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
nex-z milestones (MAGNITUDE/MAGNITUDE-2)	2025–2026	Expand MAGNITUDE to ~1,200 (subject to HA review); strong enrollment; longer-term Phase 1 data 2H25	Milestone guidance suspended pending regulatory alignment due to FDA clinical hold	Lowered/Suspended
lonvo-z HAELO topline	Mid-2026	Mid-2026	Mid-2026	Maintained
lonvo-z BLA submission	2H26	2H26	2H26	Maintained
lonvo-z U.S. launch (anticipated)	1H27	1H27	1H27	Maintained

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2)	Previous Mentions (Q-1)	Current Period (Q3)	Trend
Regulatory/legal (FDA interactions)	Enrollment ahead; plan to expand MAGNITUDE; no hold	Dosed first MAGNITUDE-2 patient; enrollment tracking ahead	FDA clinical hold on both Phase 3 studies; patient death disclosed; risk mitigation plan under development	Deteriorating
R&D execution – lonvo-z	HAELO randomization completion targeted Q3; data in 2H25	On track to complete enrollment in Q3 2025	Enrollment completed; pooled Phase 1/2 50mg data positive; topline mid-2026	Improving
Product performance – nex-z Phase 1 longer-term	Longer-term Phase 1 data expected 2H25	Longer-term data expected 2H25	AHA late-breaker: sustained deep TTR reduction, stability/improvement in cardiomyopathy metrics at 24 months	Mixed (positive data vs. hold)
Cash runway/financing	~$630.5M; runway into H1 2027	~$707.1M; runway into H1 2027	$669.9M; runway into mid-2027; $114.5M ATM proceeds	Stable/Improving

Management Commentary

“We were deeply saddened to learn that the patient… passed away last night… we are working with clinical investigators and external experts to better understand the liver-related events… and to develop our risk mitigation plan.” — John M. Leonard, M.D., CEO .
“We continue to believe in nex-z’s potential to address important unmet needs for patients with ATTR amyloidosis.” — John M. Leonard, M.D. .
“Today’s data further support our belief that lonvo-z could completely redefine the HAE treatment landscape… We are looking forward to our approaching topline readout… by mid-2026.” — John M. Leonard, M.D. .
“These longer-term [nex-z] data showed a consistent and durable reduction in TTR and stability or improvement in multiple markers of cardiomyopathy… out to 24 months.” — John M. Leonard, M.D. .

Q&A Highlights

Safety signal details: Management discussed elevated ALT (~3x ULN) and bilirubin (~2x ULN) in the deceased patient (early 80s), underscoring Hy’s Law concerns and focus on enhanced early post-dose lab monitoring and patient exclusion criteria development .
Regulatory timeline: Company awaiting formal FDA hold letter; plans to respond expeditiously and align on risk mitigation to resume Phase 3 dosing/screening .
Lonvo-z path: reaffirmed HAELO topline mid-2026, BLA 2H26; pooled Phase 1/2 data supports one-time treatment potential and favorable benefit-risk .
Analyst tone shifts: Multiple downgrades and lowered targets following hold and death disclosure, highlighting market skepticism and the importance of mechanistic clarity and mitigation strategy .

Estimates Context

Q3 2025 vs consensus: Revenue $13.82M vs $14.13M (miss); EPS $(0.92) vs $(1.00) (beat). Prior quarters: Q2 revenue beat ($14.25M vs $12.16M) and EPS beat ($(0.98) vs $(1.01)); Q1 revenue beat ($16.63M vs $11.99M) and EPS beat ($(1.10) vs $(1.27)) [*S&P Global] .
Estimate revisions likely: near-term consensus for nex-z timelines and probability of success should move lower pending FDA feedback; lonvo-z assumptions (timeline/launch) appear intact given positive execution/data .
Note: Values retrieved from S&P Global.

Key Takeaways for Investors

Safety overhang dominates: the FDA clinical hold and disclosed death are the central drivers of NTLA’s near-term risk/reward; resolution and a credible risk mitigation/exclusion plan are necessary catalysts for recovery .
Lonvo-z is the counterbalance: Phase 3 HAELO remains on track; durability and attack-free rates support a one-time treatment profile → preserves value despite nex-z uncertainty .
Financial runway supports optionality: $669.9M cash and ATM proceeds extend funding into mid-2027, enabling regulatory workstreams and lonvo-z commercialization preparations .
Trading setup: headline risk (FDA letter, additional safety disclosures, analyst downgrades) remains high; expect elevated volatility into regulatory updates; any positive FDA alignment could be a relief rally catalyst .
Estimates recalibration: consensus should cut nex-z timelines/PoS; lonvo-z assumptions maintained; model for lower collaboration revenue variability and tighter OpEx near term .
Strategic focus intact: management reiterated belief in nex-z’s potential and is advancing mitigation strategies; longer-term Phase 1 ATTR-CM data remain supportive despite the Phase 3 safety signal .
Actionable: monitor FDA formal hold letter and subsequent company response; track upcoming scientific presentations (AHA/ACAAI) and HAELO milestones; use weakness to reassess risk-adjusted lonvo-z value while applying higher discount to nex-z pending clarity .

Non-GAAP: Company primarily reports GAAP metrics; no separate non-GAAP adjustments disclosed in Q3 press materials **[1652130_0001193125-25-269479_d53244dex991.htm:2]** **[1652130_0001193125-25-269479_d53244dex991.htm:4]**.

Sources: Q3 2025 8-K press release and exhibits ; other Q3 press releases ; Oct 27 update ; FDA hold and coverage ; patient death and call details ; stock reaction . Values retrieved from S&P Global for estimates and certain EPS actuals.

Intellia Therapeutics, Inc. (NTLA)·Q3 2025 Earnings Summary