Executive Summary

Q3 2025 was execution-driven: RA selected as lead indication, FDA Fast Track granted for AlloNK + rituximab, and initial safety/translational data demonstrated deep B‑cell depletion with outpatient feasibility .
Financials stayed consistent with a pre‑revenue biotech: net loss per share of $0.88 vs S&P Global consensus of $0.868 (minor miss), with net loss of $21.5M and cash/investments of $123.0M; cash runway into Q2 2027 maintained .
OpEx tracked near flat sequentially (R&D $17.6M; G&A $5.3M) and up YoY as trials scaled; no revenue recognized .
Near‑term catalysts: initial RA response data (>15 patients) and FDA alignment on pivotal trial design in 1H26; management hosted a data webcast with Q&A on Nov 12 .
Estimates context: EPS was essentially in line with consensus; Street models should reflect elevated R&D into 2026 and sustained zero revenue until pivotal initiation; consensus revenue is $0 [GetEstimates]*.

What Went Well and What Went Wrong

What Went Well

Fast Track for AlloNK in refractory RA, establishing RA as the lead indication; CEO highlighted outpatient‑ready profile and deep B‑cell depletion potential: “we have taken an important step forward… outpatient‑ready therapy capable of achieving deep B‑cell depletion” .
Initial translational data: 23/23 analyzed patients showed non‑quantifiable peripheral CD19+ B‑cells by Day 13; depth comparable to auto‑CAR‑T and greater than rituximab alone in published studies .
Safety/tolerability: no CRS/ICANS/GvHD/hypogammaglobulinemia; only one hospitalization (unrelated skin infection) in 28 days; majority treated at community sites without oncology oversight .

What Went Wrong

Continued widening YoY net loss as trial activity scaled (Q3 net loss $21.5M vs $17.5M YoY); non‑cash SBC still a factor ($1.6M) .
EPS slightly missed S&P Global consensus (‑$0.88 actual vs ‑$0.868 consensus), reflecting higher R&D program intensity [GetEstimates]*.
CFO transition announced (Neha Krishnamohan moving to advisory role after December), introducing leadership change risk while a search is conducted .

Financial Results

Quarterly P&L and Cash (USD)

Metric	Q1 2025	Q2 2025	Q3 2025
License & development support revenue ($USD Millions)	$0.0	$0.0	$0.0
R&D expense ($USD Millions)	$17.1	$17.9	$17.6
G&A expense ($USD Millions)	$5.1	$4.9	$5.3
Other income (expense), net ($USD Millions)	$1.9	$1.6	$1.4
Net loss ($USD Millions)	$(20.3)	$(21.3)	$(21.5)
Net loss per share ($USD)	$(0.83)	$(0.87)	$(0.88)
Cash, cash equivalents & investments ($USD Millions, period-end)	$166.0	$142.4	$123.0

Q3 YoY Comparison (USD)

Metric	Q3 2024	Q3 2025
R&D expense ($USD Millions)	$13.5	$17.6
G&A expense ($USD Millions)	$4.8	$5.3
Other income (expense), net ($USD Millions)	$0.9	$1.4
Net loss ($USD Millions)	$(17.5)	$(21.5)
Net loss per share ($USD)	$(0.92)	$(0.88)

KPIs (Program Execution)

KPI	Q1 2025	Q2 2025	Q3 2025
Patients treated with AlloNK + mAb (cumulative, autoimmune)	“over a dozen patients”	“over a dozen patients”	32 patients (as of Oct 1)
Sites & setting	Global basket trial initiated; outpatient protocol (no hospitalization)	>12 sites enrolling; community rheumatology prioritization	Majority treated at community sites, outpatient administration feasible
B‑cell depletion consistency	N/A	N/A	23/23 non‑quantifiable CD19+ by Day 13; comparable to auto‑CAR‑T depth
Safety signals	Early favorable tolerability in IIT community setting	Continued favorable tolerability	No CRS/ICANS/GvHD/hypogammaglobulinemia; 1 unrelated hospitalization

Note: Company has no reportable revenue segments.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Through Q2 2027	Into Q2 2027 (Q1, Q2)	Into Q2 2027 (Q3)	Maintained
Lead indication	N/A	Lead indication to be disclosed by YE25	RA prioritized; FDA Fast Track granted	Updated (raised strategic clarity)
Initial clinical response data (RA)	1H26	1H26	1H26 (≥15 patients; several ≥6 months follow-up)	Maintained (more detail)
FDA interactions (pivotal design)	1H26	1H26 (registrational insights)	1H26 alignment on potential pivotal trial design	Maintained

No revenue, margin, OpEx, OI&E, tax rate, or dividend guidance was provided .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q3)	Trend
Outpatient feasibility/community setting	Protocol allows no hospitalization; IIT suggests outpatient management viable	All patients outpatient; majority at community sites; feasible without oncology oversight	Strengthening
Deep B‑cell depletion vs biologics/CAR‑T	Longer-term B‑NHL data in line with auto‑CAR‑T; mechanism support	23/23 patients non‑quantifiable CD19+ by Day 13; depth comparable to auto‑CAR‑T and greater than rituximab alone	Strengthening
Lead indication choice	Lead indication to be disclosed YE25	RA prioritized; Fast Track designation	Resolved positively
Regulatory path	Registrational insights expected in 1H26	FDA alignment on potential pivotal design targeted 1H26	Consistent
Trial enrollment footprint	>12 sites enrolling; global basket initiated	>100 patients treated across autoimmune/oncology (cumulative AlloNK)	Scaling
Corporate changes	N/A	CFO transition to advisory role after Dec; replacement search	Transition risk

Management hosted a webcast at 8:00 a.m. ET on Nov 12 to discuss initial safety/translational data with live Q&A .

Management Commentary

CEO (Fred Aslan): “With refractory rheumatoid arthritis now established as our lead indication and Fast Track designation granted by the FDA, we have taken an important step forward… supporting AlloNK’s profile as an outpatient‑ready therapy capable of achieving deep B‑cell depletion” .
CEO (Fred Aslan): “We believe AlloNK could be the first agent in the deep B‑cell depleting field to potentially start a global pivotal trial in refractory RA following our planned interactions with FDA in the first half of 2026” .
CMO (Subhashis Banerjee): “There were no CRS or ICANS events and a low infection rate reported… supports administration in outpatient and community rheumatology settings” .

Q&A Highlights

The company held a webcast with live Q&A to discuss the initial safety and translational data; emphasis was placed on outpatient administration feasibility and tolerability (no CRS/ICANS) .
Management reiterated the timeline: initial RA response data and FDA pivotal‑design alignment targeted for 1H26 .
Clarifications centered on the depth and consistency of B‑cell depletion and comparability to auto‑CAR‑T, and suitability of community rheumatology settings .
Note: A formal earnings call transcript is not available in the document catalog; webcast remarks are drawn from press releases and 8‑K disclosures .

Estimates Context

Metric	Q1 2025	Q2 2025	Q3 2025
Primary EPS Consensus Mean ($)	-0.71*	-0.80667*	-0.86833*
Actual EPS ($)	-0.83	-0.87	-0.88
Difference (Actual − Consensus) ($)	-0.12*	-0.06333*	-0.01167*
Outcome	Miss*	Miss*	Miss*

Revenue Consensus Mean: $0.0* for Q1–Q3 2025.
Values retrieved from S&P Global*.

Implications: EPS was essentially in line in Q3 (minor miss), with sustained zero revenue. Given RA Fast Track and near‑term data catalysts, Street models should anticipate continued elevated R&D, stable G&A, and no product revenue until a pivotal pathway is clearer .

Key Takeaways for Investors

Regulatory and strategic de‑risking: RA as lead indication and FDA Fast Track for AlloNK sharpen the registrational path toward a potential pivotal trial in 1H26 .
Compelling translational signal: rapid, consistent deep B‑cell depletion (23/23 by Day 13) with favorable safety may position AlloNK competitively vs auto‑CAR‑T, with outpatient/community delivery advantages .
Cash runway (~Q2 2027) supports delivery of RA response data and FDA interactions without near‑term financing needs under current plans .
Expense profile: R&D intensity remains the primary driver of losses; monitor sequential OpEx cadence and any shifts post CFO transition .
Near‑term catalysts: 1H26 RA response readout (>15 pts, several ≥6 months) and FDA pivotal design alignment—potential stock movers; webcast engagement underscores investor interest .
Estimate updates: Consensus should reflect continued zero revenue, modest sequential OpEx, and EPS near current run‑rate until pivotal initiation; program progress may warrant higher probability‑of‑success in RA over time [GetEstimates]*.
Risk factors: Execution in community settings, manufacturing scale‑up, and leadership transition to be monitored; no significant safety signals to date, but larger datasets are needed .

Artiva Biotherapeutics, Inc. (ARTV)·Q3 2025 Earnings Summary