Executive Summary

Q1 2025 was execution-focused: HS IND cleared and the Phase 2 TibuSURE SSc trial advanced; cash and equivalents were $170.6M with runway guided “through 2027,” while operating expenses stepped up with pipeline progress .
Net loss widened to $17.4M and diluted EPS was $(0.19), driven by higher R&D (+$6.9M YoY) and G&A (+$4.0M YoY), largely from CRO, manufacturing, compensation, and professional fees as programs scaled .
No product revenue was reported; P&L comprised operating expenses and other income (interest) with loss from operations of $(19.3)M .
Wall Street consensus via S&P Global was unavailable for Q1 2025, preventing formal beat/miss benchmarking against estimates; however, management reiterated cash runway “through 2027” and near-term clinical catalysts (HS Phase 2 initiation in Q2 2025) that may drive stock narrative .

What Went Well and What Went Wrong

What Went Well

HS program progressed: received FDA clearance for the HS IND and remained on track to initiate a Phase 2 trial in Q2 2025 . “We continued advancing trial efforts for our Phase 2 TibuSURE trial for adults with SSc, and progressed preparations for the initiation of a second Phase 2 study in HS” — CEO Robert Lisicki .
SSc program execution: ongoing Phase 2 TibuSURE trial advanced, building on Q4 2024 initiation .
Liquidity and runway: cash and equivalents were $170.6M at quarter-end, with runway anticipated through 2027, supporting clinical execution and upcoming readouts .

What Went Wrong

OpEx ramp and dilution: R&D rose to $10.5M (+$6.9M YoY) and G&A to $8.8M (+$4.0M YoY), expanding net loss to $17.4M and EPS to $(0.19); weighted-average shares more than doubled YoY to 92.96M, reflecting capital raises and exchanges, diluting per-share metrics .
Sequential cash draw: cash declined from $176.5M (FY’24 YE) and $188.2M (Q3’24) to $170.6M, consistent with increased program activity .
Lack of revenue and margin KPIs: as a clinical-stage company, no revenue/margin profile exists, limiting traditional financial benchmarking vs peers and estimates .

Financial Results

P&L Summary (Quarterly)

Metric ($USD Millions, except per-share)	Q3 2024	Q1 2025
Research & Development	$6.03	$10.47
General & Administrative	$13.29	$8.78
Total Operating Expenses	$19.32	$19.25
Loss from Operations	$(19.32)	$(19.25)
Interest Income	$2.46	$1.82
Total Other Income (Net)	$(1.38)	$1.81
Net Loss	$(20.70)	$(17.44)
Diluted EPS ($)	$(0.26)	$(0.19)
Weighted-Average Shares (Millions)	87.34	92.96

Notes: Q1 2025 “Total Other Income, Net” reflects interest income and minor other items; Q3 2024 other income includes warrant fair value changes .

Balance Sheet Liquidity

Metric ($USD Millions)	Q3 2024	FY 2024 YE (Dec-31)	Q1 2025
Cash & Cash Equivalents	$188.22	$176.50	$170.57
Accounts Payable & Accrued	$18.24	$19.51	$21.09
Total Shareholders’ Equity	$154.59	$148.36	$139.74

KPIs (Operating Drivers)

KPI ($USD Millions)	Q3 2024	Q1 2025	Commentary
R&D	$6.03	$10.47	Increase driven by CRO (+$3.7M), manufacturing (+$2.1M), and compensation (+$0.6M) as Phase 2 programs advanced .
G&A	$13.29	$8.78	YoY increase due to compensation (+$2.6M) and professional fees (+$1.2M) supporting organizational growth .
Interest Income	$2.46	$1.82	Reflects yield on cash balances; sequential decline consistent with lower average cash and rate environment impacts .

Revenue and Margins

Metric	Q3 2024	Q1 2025
Revenue ($USD Millions)	— (no revenue line reported in statements)	— (no revenue line reported in statements)
Net Income Margin %	n/a (no revenue reported)	n/a (no revenue reported)

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Multi-year	Through 2027 (Q3’24 and FY’24 releases)	Through 2027	Maintained
HS Phase 2 Initiation (tibulizumab)	Q2 2025	Initiate in Q2 2025 (Q3’24)	Initiate in Q2 2025; IND cleared in Q1 2025	Maintained on timing; de-risked by IND clearance
SSc Phase 2 (TibuSURE) Status	Q4 2024 initiation; ongoing thereafter	Initiate in Q4 2024 (Q3’24)	Ongoing Phase 2 trial advanced in Q1 2025	Progressed as planned
Orphan Drug Designation (SSc)	2024–2025	Application submitted in Q4 2024	Monitoring; no update provided in Q1 2025	No change disclosed

No financial guidance provided on revenue, margins, OpEx, OI&E, or tax rate .

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript or webcast transcript was available via our document tools; narrative drawn from press releases.

Topic	Previous Mentions (Q3 2024)	Previous Mentions (FY 2024)	Current Period (Q1 2025)	Trend
SSc (Tibulizumab; TibuSURE)	Protocol finalized; Phase 2 initiation in Q4 2024; Orphan Drug app submitted	Phase 2 initiated in Dec 2024	Ongoing Phase 2 advanced	Execution progressing on plan
HS (Tibulizumab)	CRO selected; Pre-IND submitted; IND expected Q1 2025; Phase 2 initiation in Q2 2025	IND active; Phase 2 initiation planned Q2 2025	IND cleared; Phase 2 initiation expected Q2 2025	Milestones de-risked; timeline maintained
Liquidity/Runway	Cash $188.2M; runway through 2027	Cash $176.5M YE; runway through 2027	Cash $170.6M; runway through 2027	Cash trending lower with spend; runway reiterated
Organization/Leadership	Warrant exchange; ATM program	Expanded leadership; raised $112.5M; SAB established	SVP Dev Ops appointment to strengthen clinical execution	Scaling for trials
External Data Monitoring (IL-7/TSLP, IL-33/ST2)	Ongoing monitoring of peer programs	Monitoring continues	Continued translational work and strategy evaluation	Ongoing; informs portfolio choices

Management Commentary

“The first quarter of 2025 reflected steady progress across our clinical and operational priorities… We believe we are well-positioned to move our programs forward thoughtfully and purposefully.” — Robert Lisicki, CEO .
“We made significant progress toward initiating our first Phase 2 trial of tibulizumab in SSc… We’ve worked closely with our CRO to begin trial readiness and prepare for site activation.” — Robert Lisicki (Q3 2024 release) .

Q&A Highlights

No Q1 2025 earnings call transcript was available; therefore, no Q&A highlights or clarifications can be provided based on primary call materials.

Estimates Context

S&P Global Wall Street consensus for Q1 2025 EPS and revenue was unavailable via our data tool, so formal beat/miss analysis vs S&P is not possible for this quarter [GetEstimates — Q1 2025 returned no data].
Implication: With no revenue reported and EPS driven primarily by OpEx scale and interest income, estimate revisions (when available) will likely key off planned OpEx cadence and trial timing rather than top-line or margin changes .

Key Takeaways for Investors

Near-term clinical catalyst: HS Phase 2 initiation in Q2 2025 after IND clearance; continued TibuSURE progress in SSc — watch for enrollment updates and early signals to drive sentiment .
Liquidity supports multi-year execution: $170.6M cash; runway guided through 2027 — funding risk appears contained near term though quarterly cash declines reflect advancing programs .
Operating expense inflection: R&D and G&A stepped up with CRO/manufacturing and organizational build-out — expect sustained OpEx as Phase 2 trials progress; EPS will track OpEx and interest income .
No revenue/margin benchmarks: Traditional comp tables are inapplicable; focus on clinical milestones, regulatory events, and cash utilization to gauge value creation .
Dilution dynamics: Weighted-average shares rose meaningfully YoY (92.96M vs 46.91M), impacting per-share metrics — monitor ATM usage and future financing cadence .
Pipeline optionality: Crebankitug (IL-7/TSLP) and torudokimab (IL-33/ST2) provide follow-on opportunities; ongoing translational and external data monitoring could inform indication selection and portfolio prioritization .
Trading lens: Stock reactions likely tied to trial initiations, enrollment progress, regulatory designations (e.g., Orphan outcomes for SSc), and any interim data or operational updates; lack of S&P consensus limits near-term beat/miss catalysts, elevating event-driven dynamics .

Zura Bio Ltd (ZURA)·Q1 2025 Earnings Summary