Executive Summary

Q1 2025 delivered a narrower net loss and an EPS beat: Net loss was $71.3M and EPS was -$0.49 vs Wall Street consensus of -$0.565, a positive surprise of ~$0.08, driven by lower operating expenses versus Q4 2024 and higher interest income . EPS consensus values retrieved from S&P Global.*
Operating expenses stepped down to $75.9M from $122.0M in Q4 2024 (elevated by prior manufacturing milestone payments), while cash, cash equivalents and marketable securities increased to $638.8M after a $287.5M follow-on offering, extending runway for Phase 3 programs .
Guidance update in the quarter: ENTRUST (SHTG) topline moved to Q1 2026 after the decision to unblind at Week 52 instead of Week 26; ENLIGHTEN-Fibrosis (MASH F2–F3) and ENLIGHTEN-Cirrhosis (MASH F4) histology data timelines were maintained for 1H 2027 and 2028, respectively .
Management emphasized “strong momentum” and positioning pegozafermin as a leading candidate in MASH, citing a Hepatology meta-analysis indicating favorable efficacy and “best-in-class relative risk reduction,” alongside a flexible global manufacturing strategy (including US drug product) as a readiness catalyst .

What Went Well and What Went Wrong

What Went Well

“We have entered 2025 with strong momentum… pegozafermin [is] well positioned as a leading candidate to treat this large and underserved patient population,” supported by a published meta-analysis in Hepatology (2025) highlighting efficacy for fibrosis improvement and MASH resolution .
Balance sheet strength: Cash, cash equivalents, and marketable securities rose to $638.8M, backed by a $287.5M follow-on offering in Q1 and supplemented by a $150M credit facility with $35M drawn, providing flexibility to execute Phase 3 programs and commercial readiness .
Manufacturing optionality: “Flexible, global manufacturing strategy” with “alternative CDMOs for each step” and US drug product capability; this enhances resilience to macro/geopolitical changes and supports scale-up ahead of potential filings .

What Went Wrong

ENTRUST timeline slip: The trial will now be unblinded at Week 52 (not Week 26), pushing topline to Q1 2026; this extends the path to potential SHTG filing and is an execution/timing headwind vs prior expectations of 2H 2025 26-week data .
Elevated R&D intensity YoY: R&D expenses increased to $64.4M in Q1 2025 vs $47.4M in Q1 2024 due to Phase 3 ENLIGHTEN enrollment and higher personnel costs, widening the YoY net loss to $71.3M from $51.7M .
No revenue contribution: The company continues to report operating losses without product revenue; expense profile and clinical timelines drive financials and investor focus, raising sensitivity to execution on pivotal study milestones .

Financial Results

Income Statement and Operating Metrics

Metric ($USD Millions unless noted)	Q3 2024	Q4 2024	Q1 2025
Total Operating Expenses	$151.938	$122.005	$75.909
R&D Expenses	$141.441	$111.300	$64.394
G&A Expenses	$10.497	$10.702	$11.515
Net Loss	$149.073	$118.354	$71.275
Net Loss per Share ($)	-$1.39	-$1.02	-$0.49
Interest Income and Other, net	$5.431	$5.099	$6.038
Interest Expense	$2.362	$1.191	$1.267
Weighted-Average Shares (Millions)	107.075	115.956	146.365

Note: The company’s press releases furnish operating expense and net loss data but do not present revenue, gross margin, or segment revenue/margins for these periods .

Balance Sheet Highlights

Metric ($USD Millions)	Q3 2024	Q4 2024	Q1 2025
Cash, Cash Equivalents & Marketable Securities	$423.774	$439.955	$638.780
Total Assets	$458.297	$478.685	$685.031
Total Stockholders’ Equity	$378.102	$400.789	$605.458
Total Current Liabilities	$39.131	$36.129	$37.884
Non-Current Liabilities	$41.064	$41.767	$41.689

YoY Comparison (Q1 2025 vs Q1 2024)

Metric ($USD Millions unless noted)	Q1 2024	Q1 2025
R&D Expenses	$47.428	$64.394
G&A Expenses	$9.849	$11.515
Net Loss	$51.681	$71.275
Net Loss per Share ($)	-$0.54	-$0.49
Weighted-Average Shares (Millions)	95.847	146.365

Wall Street Consensus vs Actuals

Metric	Q3 2024	Q4 2024	Q1 2025
Primary EPS Consensus Mean ($)	-0.64204*	-0.75938*	-0.56512*
Actual Diluted EPS ($)	-1.39	-1.02	-0.49
Revenue Consensus Mean ($)	535,710*	0*	0*
Primary EPS - # of Estimates	6*	5*	7*
Revenue - # of Estimates	7*	5*	6*

Values retrieved from S&P Global.*

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
ENTRUST topline (SHTG)	Program readout timing	“Topline 26-week data in 2H 2025” (preliminary)	“Topline data in Q1 2026 after unblinding at Week 52” ; maintained in Q1 PR	Lowered/delayed (timeline extended)
ENLIGHTEN-Fibrosis histology (MASH F2–F3)	Program readout timing	1H 2027	1H 2027	Maintained
ENLIGHTEN-Cirrhosis histology (MASH F4)	Program readout timing	2028	2028	Maintained
Manufacturing strategy	Supply chain / CMC	Commercial-scale manufacturing and CMC feedback from FDA/EMA	Flexible global strategy, alternative CDMOs, optionality incl. US drug product	Enhanced clarity/optionality
Capital position	Liquidity	~$440M cash at 12/31/2024 (prelim)	$638.8M cash at 3/31/2025 after $287.5M offering	Strengthened

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was found in the document catalog after targeted search; themes below reflect management narrative across Q3 2024, Q4 2024, and Q1 2025 press releases .

Topic	Previous Mentions (Q3/Q4)	Current Period (Q1 2025)	Trend
Clinical timelines (MASH & SHTG)	ENLIGHTEN trials initiated and enrolling; ENTRUST enrollment completed; initial expectation of 26-week topline in 2H 2025	ENTRUST topline moved to Q1 2026 (Week 52 unblinding); ENLIGHTEN timelines reiterated (1H 2027, 2028)	Mixed: MASH maintained; SHTG delayed
Regulatory readiness	FDA/EMA feedback on clinical and CMC requirements; scale-up plans	Manufacturing strategy elaborated; optionality incl. US drug product	Strengthened operational clarity
Manufacturing/supply chain	BiBo milestone payments; credit facility expanded	Diversified supply chain via alternative CDMOs; resilience to macro/geopolitical shifts	Improved resiliency
Financing/liquidity	Follow-ons in 4Q 2024; credit facility up to $150M; cash ~$440M YE	$287.5M offering closed; cash $638.8M at 3/31/2025	Strengthened
Macro/tariffs risk	General macro risks noted	Tariffs specifically cited as risk in forward-looking statements	Elevated risk flagging
R&D execution	Heavy R&D driven by milestones and Phase 3 initiations	R&D YoY higher with ENLIGHTEN rollout; expenses moderated QoQ vs Q4 peak	Execution ongoing; expense normalization QoQ

Management Commentary

“We have entered 2025 with strong momentum, fueled by continued progress in our two global Phase 3 trials in advanced MASH… A recently published meta-analysis in Hepatology ranked pegozafermin among the most effective agents for achieving fibrosis improvement and MASH resolution—reinforcing its differentiated profile and the growing recognition of its potential.” — Rohan Palekar, CEO .
“Looking ahead, we continue to expect topline results from our Phase 3 ENTRUST trial in SHTG in first quarter of 2026, followed by data readouts from ENLIGHTEN-Fibrosis in the first half of 2027 and ENLIGHTEN-Cirrhosis in 2028—the latter two of which are intended to support the accelerated approval of pegozafermin… To support our development and commercial readiness efforts, we have implemented a flexible, global manufacturing strategy… including the United States for the drug product.” — Rohan Palekar, CEO .
“2024 marks a tremendous year of execution and progress… we look forward to executing on our clinical trials and completing all scale-up and regulatory activities to position us for a successful BLA filing, pending positive results in the Phase 3 trials.” — Rohan Palekar, CEO .

Q&A Highlights

No Q1 2025 earnings call transcript was available in the document catalog despite targeted searches for “earnings-call-transcript” for ETNB; therefore, Q&A themes and guidance clarifications from a call cannot be provided for this period [earnings-call-transcript search returned 0].

Estimates Context

Q1 2025 EPS of -$0.49 beat consensus of -$0.565 by ~$0.08; Q4 2024 EPS of -$1.02 was more negative than consensus of -$0.759; Q3 2024 EPS of -$1.39 was more negative than consensus of -$0.64204. EPS consensus values retrieved from S&P Global.* Actual EPS values cited above from company press releases .
Revenue consensus for Q1 2025 and Q4 2024 was $0; the company did not report revenue in furnished press releases for these periods, reinforcing that expense control and interest income are key near-term P&L drivers. Consensus values retrieved from S&P Global.* Company disclosures do not include revenue in the presented tables .

Key Takeaways for Investors

EPS beat in Q1 2025 was driven by a sequential decline in operating expenses versus the Q4 2024 peak; this is supportive of near-term sentiment while the company remains pre-revenue . EPS consensus values retrieved from S&P Global.*
Liquidity strengthened materially: $638.8M in cash/marketable securities at 3/31/2025 following a $287.5M follow-on; supports multi-year execution across Phase 3 programs and commercial readiness build .
Guidance reset: ENTRUST topline shifted to Q1 2026 after Week 52 unblinding—this delays SHTG timing but aligns to bias-minimized data; ENLIGHTEN timelines maintained (1H 2027, 2028) .
Manufacturing optionality across geographies (incl. US drug product) and diversified CDMO footprint mitigate supply chain/geopolitical risks—important for scale-up and future BLA readiness .
Near-term narrative drivers: clinical enrollment progress, any regulatory interactions, and financing/cash runway; macro/tariffs cited as risk, suggesting a watch item for potential COGs/supply chain impacts .
Estimate models may adjust for lower near-term operating expenses vs Q4’s milestone-impacted levels and for the extended ENTRUST timeline; maintain focus on interest income as a partial offset to OpEx .
Medium-term thesis hinges on ENLIGHTEN histology readouts intended to support accelerated approval and ENTRUST efficacy/safety in SHTG; meta-analysis supports pegozafermin’s profile, but regulatory and execution risks remain .

89bio, Inc. (ETNB)·Q1 2025 Earnings Summary