Executive Summary

Q1 2025 was execution-heavy: ARTV secured FDA IND clearance and began initiating a global Phase 2a basket trial of AlloNK + rituximab in refractory RA, Sjögren’s, IIM, and SSc; management set near-term catalysts with initial safety/translational data and lead indication by year-end 2025, and first clinical response readout in 1H 2026 .
Financially, revenue was $0 and net loss widened to $20.3M as R&D spend ramped with autoimmune trials; diluted EPS was $(0.83) vs S&P Global consensus of $(0.71), a miss of $0.12; revenue matched $0 consensus estimate .
Balance sheet remains a strength: cash, cash equivalents and investments were $166.0M, extending runway into Q2 2027, supporting multiple data catalysts (ASGCT B‑NHL update, autoimmune translational data, lead indication selection) .
Strategic narrative emphasized outpatient “community setting” administration, deep B‑cell depletion, and longer-term B‑NHL outcomes “in line with” approved auto‑CAR‑T therapies, positioning AlloNK for accessibility and differentiated profile as data mature .

What Went Well and What Went Wrong

What Went Well

IND clearance and trial initiation: FDA-cleared IND and global site initiation underway for the company-sponsored Phase 2a basket trial in refractory RA, Sjögren’s, IIM, and SSc; notably the first company-sponsored allogeneic cell therapy trial in RA and Sjögren’s in the U.S. .
Differentiation and clinical rationale: Management highlighted longer-term B‑NHL data “in line with approved auto‑CAR‑T therapies,” supporting AlloNK’s ability to drive deep and durable B‑cell depletion and outpatient feasibility; ASGCT presentations to showcase durability and manufacturing scalability (CD16 expression, >40 lots, 4‑year shelf life viability/cytotoxicity) .
Balance sheet and visibility: $166.0M in cash, cash equivalents and investments and stated runway into Q2 2027; clear milestones set—initial safety/translational data and lead indication by YE25; first clinical response data in 1H26 .
- Quote: “We remain well capitalized to generate meaningful data sets and to differentiate ourselves over time…” — CEO Fred Aslan, M.D. .

What Went Wrong

EPS miss vs consensus: Diluted EPS of $(0.83) missed S&P Global consensus of $(0.71) as OpEx scaled with clinical expansion .
Operating expense escalation: R&D rose to $17.1M (from $11.2M YoY) and G&A to $5.1M (from $3.6M YoY), lifting total OpEx to $22.2M vs $14.7M last year, contributing to a wider net loss of $20.3M vs $14.0M YoY .
No revenue and no discrete Q4 2024 quarterly print: Q1 2025 revenue remained $0; ARTV did not furnish a separate Q4 2024 quarterly press release (provided FY 2024 results instead), limiting strict sequential comparisons from Q4 to Q1 .

Financial Results

P&L Snapshot – Quarter over Quarter (oldest → newest)

Metric	Q3 2024	Q1 2025
License/Development Revenue ($M)	$0.0	$0.0
R&D Expense ($M)	$13.5	$17.1
G&A Expense ($M)	$4.8	$5.1
Total Operating Expenses ($M)	$18.3	$22.2
Other Income (Net) ($M)	$0.9	$1.9
Net Income (Loss) ($M)	$(17.5)	$(20.3)
Diluted EPS ($)	$(0.92)	$(0.83)

Notes: Sequential comparison uses Q3 2024 as the prior available quarterly update due to lack of a separate Q4 2024 quarterly press release .

P&L Snapshot – Year over Year (oldest → newest)

Metric	Q1 2024	Q1 2025
License/Development Revenue ($M)	$0.25	$0.00
R&D Expense ($M)	$11.16	$17.05
G&A Expense ($M)	$3.59	$5.12
Total Operating Expenses ($M)	$14.74	$22.17
Other Income (Net) ($M)	$0.53	$1.86
Net Income (Loss) ($M)	$(13.96)	$(20.31)
Diluted EPS ($)	$(17.24)	$(0.83)

Cash and Liquidity

Metric	Q3 2024 (9/30)	FY 2024 (12/31)	Q1 2025 (3/31)
Cash, Cash Equivalents & Investments ($M)	$199.6	$185.4	$166.0
Stated Cash Runway	—	“at least through end of 2026”	“into Q2 2027”

Q1 2025 vs S&P Global Consensus

Metric	Actual	Consensus	Surprise
Revenue ($M)	$0.0	$0.0*	In line*
Diluted EPS ($)	$(0.83)	$(0.71)*	—$0.12 (miss)*

Values marked with * are retrieved from S&P Global.

KPIs (execution proxies)

Patients/clinical progress milestones and manufacturing durability highlighted via upcoming ASGCT presentations and trial initiations (qualitative KPIs) .
No segment reporting applies; ARTV is a single operating segment clinical-stage company (no separate commercial revenue lines) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Initial autoimmune program data timing	2025	“Initial data … expected H1 2025” (from Phase 1/1b or IIT)	“Initial safety and translational data … and lead indication selection by YE 2025”	Pushed later (H1’25 → YE’25)
First clinical response data in lead autoimmune indication	2026	Not previously specified (FY update didn’t provide this milestone)	“Initial clinical response data … in 1H 2026”	New milestone added
Cash runway	Multi-year	“At least through end of 2026”	“Into Q2 2027”	Extended
B‑NHL data update	2025	“Updated data to be presented at a medical conference in 2025”	“Longer-term clinical data to be presented at ASGCT May 2025”	Firmed timing (ASGCT)

Earnings Call Themes & Trends

No earnings call transcript was available for Q1 2025 in our document set.

Topic	Previous Mentions (Q3 2024)	Previous Mentions (FY 2024)	Current Period (Q1 2025)	Trend
Autoimmune expansion	First IIT patient dosed; SLE Ph1/1b ongoing; initial autoimmune data expected H1’25	Reiterated initial autoimmune data H1’25; leadership hires in autoimmune	IND cleared; Phase 2a basket trial initiation underway; YE’25 translational data and lead indication selection targeted	Accelerating, clearer plan but timing shifted later
Community-setting feasibility	IIT at community rheumatology clinic highlights outpatient potential	Emphasized outpatient compatibility in NHL	Protocol allows continuous enrollment; no inpatient requirement; prioritizing community sites	Strengthening
B‑NHL durability vs auto‑CAR‑T	AlloNK NHL data maturing; outpatient-compatible regimen	Updated NHL data planned for 2025 conference	ASGCT presentation; “in line with” auto‑CAR‑T CR rates and median DoR in aggressive B‑NHL (CAR‑T naïve)	Positive maturation
Manufacturing scalability	Not highlighted	Not highlighted	ASGCT poster: high CD16 expression, uniform expansion >40 lots, high viability/cytotoxicity after 4 years shelf life	Positive validation
Capital runway	Robust post-IPO	“At least through end 2026”	“Into Q2 2027”	Extended
Regulatory	—	—	IND clearance for basket trial	Positive

Management Commentary

Strategic focus: “We have initiated regulatory submissions globally for our company‑sponsored basket trial… Notably, we are first to announce a company‑sponsored allogeneic cell therapy trial in rheumatoid arthritis and Sjögren’s disease in the U.S.” — Fred Aslan, M.D., CEO .
Data roadmap and differentiation: “By the end of 2025, we plan on sharing initial safety and translational data… In the first half of 2026, we expect to share clinical response data in our lead indication…” — Fred Aslan, M.D. .
NHL validation: “Our longer‑term aggressive B‑NHL data is maturing into a leading data set, in line with approved auto‑CAR‑T therapies, providing proof of concept of AlloNK’s ability to deplete B‑cells deeply and durably.” — Fred Aslan, M.D. .
Capital position: “We remain well capitalized to generate meaningful data sets and to differentiate ourselves…” — Fred Aslan, M.D. .

Q&A Highlights

No Q1 2025 earnings call transcript was located; therefore, no Q&A to report for this period.

Estimates Context

Q1 2025 revenue: actual $0.0 vs S&P Global consensus $0.0*; in line .
Q1 2025 diluted EPS: actual $(0.83) vs S&P Global consensus $(0.71); miss of $0.12 .
Coverage depth: EPS estimates count 6*; revenue estimates count 6*.
Values marked with * are retrieved from S&P Global.

Implications: Near-term estimate revisions likely focus on operating expense run‑rate and timing of data milestones (YE’25 translational data; 1H’26 clinical response). With no revenue expected near term, EPS remains largely a function of OpEx cadence and interest income .

Key Takeaways for Investors

Clinical momentum with broadened scope: FDA IND clearance and Phase 2a basket trial initiation across multiple autoimmune indications expands optionality; initial translational data and lead indication decision by YE’25, clinical response readout in 1H’26 are the key stock catalysts .
Differentiation theme: Outpatient/community-site administration and B‑cell depletion depth/durability (NHL) underpin the emerging target product profile relative to complex CAR‑T paradigms .
Balance sheet provides runway into Q2 2027, enabling multi‑milestone readouts without near‑term financing reliance; this reduces downside risk into catalysts .
EPS miss driven by higher OpEx as trials scale; investors should expect OpEx to remain elevated as dosing expands and cohorts escalate (consistent with R&D growth YoY) .
Timeline shift: Initial autoimmune readouts reframed from H1’25 to YE’25 for safety/translational outputs; set expectations for 1H’26 efficacy readout in lead indication .
Near-term events to watch: ASGCT (NHL durability/manufacturing), regulatory/site activations and enrollment velocity in the basket trial, SLE combo cohorts, and community-setting feasibility updates .
Trading setup: Shares likely to trade on trial start updates, conference data quality, and clarity on lead indication selection; OpEx and cash runway should anchor downside barring adverse safety signals .

Additional Source Documents Reviewed

Q1 2025 8‑K and press release (Item 2.02, Exhibit 99.1) .
FY 2024 8‑K and press release (for context/prior period milestones) .
Q3 2024 8‑K and press release (prior quarter comparison) .

S&P Global Data: Q1 2025 consensus figures (revenue, EPS, estimate counts) used for estimate comparisons (see asterisks).

Artiva Biotherapeutics, Inc. (ARTV)·Q1 2025 Earnings Summary