Executive Summary

Q1 2025 EPS of $(0.90) beat S&P Global consensus of $(0.99) by $0.09*, driven by higher interest income and disciplined OpEx pacing amid Phase 3 execution .
Cash, cash equivalents and marketable securities rose to $1.128B, extending runway into 2028, supported by a $402.5M follow-on offering completed in January 2025 .
Clinical highlight: statistically significant reversal of compensated cirrhosis (F4) at Week 96 in Phase 2b SYMMETRY—39% responders on 50mg EFX vs 15% placebo (completer), and 29% vs 11% (ITT), a notable efficacy signal and likely stock narrative catalyst .
Guidance maintained: Phase 3 SYNCHRONY Real-World topline remains H1 2026; Histology 52-week primary endpoints in H1 2027; Outcomes program ongoing—NEJM publication and EASL presentations reinforce visibility on near- to medium-term milestones .

What Went Well and What Went Wrong

Statistically significant fibrosis improvement and reversal of compensated cirrhosis at Week 96 in SYMMETRY, with corroborating non-invasive markers (ELF −0.53; FibroScan −24% for 50mg EFX) .
Strengthened balance sheet and extended runway via the $402.5M offering; cash grew to $1.128B as of March 31, 2025 .
Clear strategic momentum: Phase 3 SYNCHRONY program progressing across Outcomes, Histology, and Real-World; NEJM publication enhances clinical credibility and investor confidence .
- “We believe the SYMMETRY week 96 results highlight the potential of EFX to transform the treatment of MASH…” — Andrew Cheng, CEO .

Primary endpoint at Week 36 in SYMMETRY showed only numerical improvement versus placebo without statistical significance, making longer treatment essential for signal separation .
OpEx rose year-over-year (R&D $69.6M vs $50.7M; G&A $11.3M vs $9.3M), reflecting Phase 3 scale-up—heightens cash burn sensitivity despite strong runway .
No revenue generation; ongoing net losses persist as the company remains clinical-stage (Q1 2025 net loss $70.7M vs $53.3M in Q1 2024) .

Metric	Q3 2024	Q4 2024	Q1 2025
Total Operating Expenses ($USD Millions)	$81.7	$78.0	$80.9
Net Loss ($USD Millions)	$72.705	$70.024	$70.725
Diluted EPS ($USD)	$(1.05)	$(0.99)	$(0.90)
Cash & Marketable Securities ($USD Millions)	$787.1	$743.1	$1,128.3

Notes:

No revenue was reported; company remains clinical-stage with financials driven by R&D and G&A .

Metric	Q1 2024	Q1 2025
Research & Development ($USD Millions)	$50.7	$69.6
General & Administrative ($USD Millions)	$9.3	$11.3
Total Operating Expenses ($USD Millions)	$60.0	$80.9
Net Loss ($USD Millions)	$53.344	$70.725
Net Loss per Share ($USD)	$(0.90)	$(0.90)

Metric	Consensus	Actual	Delta
EPS ($USD)	$(0.99)*	$(0.90)	+$0.09*
Revenue ($USD Millions)	$0.0*	N/A	N/A

Estimates based on S&P Global consensus: 5 EPS estimates; 5 revenue estimates*.
*Values retrieved from S&P Global.

Endpoint	Placebo	EFX 28mg	EFX 50mg
≥1-stage fibrosis improvement without MASH worsening (Completer, N=134)	15%	29%	39%
≥1-stage fibrosis improvement without MASH worsening (ITT, N=181)	11%	21%	29%
ELF score change (LS mean)	+0.22	−0.34	−0.53
Liver stiffness change by FibroScan (%)	−8%	−18%	−24%

Metric	Period	Previous Guidance	Current Guidance	Change
SYNCHRONY Real-World topline	H1 2026	H1 2026	H1 2026	Maintained
SYNCHRONY Histology 52-week primary endpoints	H1 2027	H1 2027	H1 2027	Maintained
SYNCHRONY Outcomes histology (96-week Cohort 1)	Ongoing	Cohort 1 histology after 96 weeks	Cohort 1 histology after 96 weeks	Maintained
Cash runway	Through 2028	Through 2028	Through 2028	Maintained

Note: No Q1 2025 earnings call transcript was published; company hosted a January 27 investor webcast to present SYMMETRY Week 96 results .

Topic	Previous Mentions (Q3 2024, Q4 2024)	Current Period (Q1 2025)	Trend
R&D execution / Phase 3 progress	First patients dosed in Outcomes; Real-World and Histology on track	Phase 3 SYNCHRONY timelines maintained; Real-World enrollment completed in double-blind; program scale emphasized	Stable to positive
Clinical efficacy (EFX)	Week 96 SYMMETRY readout expected Feb 2025	Statistically significant fibrosis improvement and cirrhosis reversal at Week 96; subgroup robustness	Strongly positive
AI/technology in pathology	HARMONY analyses reinforced with AI-based qFibrosis at AASLD 2024	EASL 2025 presentations: qFibrosis concurrence with NITs; earlier detection insights	Positive adoption
Capital / runway	$797.8M YE cash; offering planned/closed in Jan 2025	$402.5M offering closed; $1.128B cash; runway to 2028	Strengthened
Regulatory/legal backdrop	N/A in earnings PR; general biotech environment	NEJM publication of SYMMETRY; heightened credibility	Positive

“We reported an unprecedented statistically significant reversal of cirrhosis due to MASH… Publication… in the New England Journal of Medicine underscores the importance of these results…” — Andrew Cheng, President & CEO .
“Publication of the Phase 2b SYMMETRY trial results in the New England Journal of Medicine is a significant milestone that affirms the strength of our clinical data…” — Kitty Yale, Chief Development Officer .
“EFX’s powerful anti-fibrotic activity… has the potential to be the most substantial medical breakthrough…” — Mazen Noureddin, M.D., Principal Investigator, SYMMETRY .

No formal Q1 2025 earnings call transcript available; the company held an investor webcast to present preliminary topline Week 96 SYMMETRY results on January 27, 2025 .
No published Q&A details to clarify guidance beyond press-release commentary; Phase 3 timelines and runway reiterated .

EPS beat: Actual $(0.90) vs S&P Global consensus $(0.99), +$0.09*, reflecting higher interest and other income ($11.3M) alongside controlled G&A growth .
Revenue consensus was $0 given clinical-stage status; results align with no reported revenue*.
With Week 96 efficacy now validated, estimate revisions are more likely to reflect accelerated probability of success and potential value attribution to Phase 3 outcomes milestones rather than near-term P&L.
*Values retrieved from S&P Global.

Efficacy inflection: Week 96 SYMMETRY data deliver statistically significant fibrosis improvement and cirrhosis reversal, corroborated by ELF and FibroScan changes—key de-risking for Outcomes and Histology programs .
Capital strength: $1.128B cash and runway into 2028 provide funding for Phase 3 completion and potential regulatory filings without near-term dilution risk .
Visibility: NEJM publication and EASL 2025 presentations should sustain buy-side attention; catalysts include Real-World topline in H1 2026 and Histology primary endpoints in H1 2027 .
Estimates: EPS beat vs S&P consensus in Q1 2025 underscores financial stewardship amid clinical scale-up; future estimate changes will track trial timelines more than quarterly P&L given no revenue*.
Risk monitor: OpEx growth is necessary for Phase 3 execution but elevates quarterly net losses; maintain focus on trial recruitment, event rates, and regulatory interactions .
Strategic narrative: EFX’s differentiated anti-fibrotic activity across F2-F4 stages positions Akero as a leading MASH candidate; subgroup robustness (non-GLP-1 users, T2D) strengthens commercial optionality .
*Values retrieved from S&P Global.