Executive Summary

Q3 2025 was operationally focused with clinical milestones reaffirmed; EPS modestly beat S&P Global consensus and cash increased sequentially, while operating spend and net loss rose year over year .*
EPS came in at $-0.37 vs consensus $-0.43 (12 estimates), a beat; revenue remains $0 given clinical-stage status.*
Guidance reiterated: topline 36-week ACCESS and ACCESS II data by year-end 2025; first-in-human for ACCG-2671 targeted by year-end; cash runway “through at least 2027” (excludes Phase 3 registrational studies) .
Near-term stock catalysts center on year-end obesity readouts (ACCESS/ACCESS II) and initiation of oral amylin Phase 1, with management emphasizing differentiation through oral, combinable therapies .

What Went Well and What Went Wrong

What Went Well

Management reaffirmed year-end 2025 topline readouts for ACCESS and ACCESS II and highlighted leadership ambitions in oral small molecules for obesity: “We are on schedule to report topline data by year-end 2025…We believe the future of obesity treatment lies in multiple options and includes oral, combinable, and broadly accessible therapies” — Raymond Stevens, Ph.D., CEO .
Cash, cash equivalents and short-term investments grew sequentially to $799.0M (from $786.5M in Q2), supporting operations and key milestones through at least 2027 (ex-Phase 3) .
Supplementary studies (maintenance switch from injectable GLP-1 to aleniglipron; body composition; T2DM cohort) advanced, positioning Phase 3 design and competitive differentiation .

What Went Wrong

Operating expenses rose sharply YoY (R&D $59.0M vs $32.6M; G&A $14.8M vs $13.2M), reflecting heavier clinical and infrastructure spend .
Net loss widened to $65.7M vs $34.0M YoY, even with higher interest income, underscoring spend ramp ahead of pivotal program decisions .
Cash runway guidance excludes Phase 3 registrational costs, implying future financing/partnership needs as programs progress .

Financial Results

Metric	Q1 2025	Q2 2025	Q3 2025
Cash, Cash Equivalents & Short-term Investments ($USD Millions)	$836.9	$786.5	$799.0
R&D Expense ($USD Millions)	$42.9	$54.7	$59.0
G&A Expense ($USD Millions)	$13.4	$15.7	$14.8
Total Operating Expenses ($USD Millions)	$56.3	$70.5	$73.8
Net Loss ($USD Millions)	$46.8	$61.7	$65.7
Non-cash Share-based Comp ($USD Millions)	$5.9	$7.5	$7.5

EPS vs Estimates (S&P Global):

Metric	Q1 2025	Q2 2025	Q3 2025
Primary EPS Consensus Mean ($)	-0.231*	-0.363*	-0.429*
Actual EPS ($)	-0.27*	-0.36*	-0.37*
Primary EPS - # of Estimates	9*	9*	12*
Revenue Consensus Mean ($USD Millions)	0.0*	0.0*	0.0*

Notes: Values retrieved from S&P Global.*

Segment breakdown: N/A (no commercial revenues) .

KPIs:

KPI	Q1 2025	Q2 2025	Q3 2025
Cash Runway Commentary	“through at least 2027” (ex-Phase 3)	“through at least 2027” (ex-Phase 3)	“through at least 2027” (ex-Phase 3)
ACCESS/ACCESS II Status	Fully enrolled; 36-week topline by YE25	On track; extended data collection added	On track for topline by YE25
Supplementary Studies	Announced (switch, body composition, T2DM)	Initiated/starting timelines detailed	Enrollment ongoing; usage defined

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
ACCESS topline (36-week)	YE 2025	“on track by year-end 2025” (Q1, Q2)	“on schedule by year-end 2025” (Q3)	Maintained
ACCESS II topline (36-week)	YE 2025	“on track by year-end 2025” (Q1, Q2)	“on schedule by year-end 2025” (Q3)	Maintained
ACCG-2671 Phase 1 start	YE 2025	“anticipated by year-end 2025” (Q1, Q2)	“expected by year-end 2025” (Q3)	Maintained
Cash Runway	Multi-year	“through at least 2027” (ex-Phase 3) (Q1, Q2)	“through at least 2027” (ex-Phase 3) (Q3)	Maintained
Supplementary GLP-1 studies (switch/body comp/T2DM)	2025–2026	Initiation/starts guided (Q2)	Enrollment ongoing; usage in Phase 3 design (Q3)	Progressing per plan

Earnings Call Themes & Trends

Note: A formal Q3 earnings call transcript was not available. We leverage a Morgan Stanley fireside chat (Sept 10, 2025) for narrative continuity.

Topic	Previous Mentions (Q2, Q1)	Current Period (Q3)	Trend
Obesity GLP-1 oral strategy	Oral, once-daily GLP-1; topline by YE25	“We are on schedule…year-end 2025”	Consistent execution
Benchmarking vs orforglipron	n/a	Plan to benchmark efficacy/tolerability; focus on 36W comparators and titration	Active competitive framing
FDA guidance for chronic weight management	n/a	Clarity on Phase 3 design: no CV outcomes required; placebo sizing discussed	Regulatory de-risking
Combinability strategy (GLP-1 + Amylin/GIP)	Pipeline combinations noted	Emphasis on oral combos; once-daily target profile	Strengthening
Maintenance switch from injectables	Announced	Enrollment ongoing; 12-week maintenance assessment	Executing
Cash runway and Phase 3 needs	“through at least 2027” (ex-Phase 3)	Reiterated	Neutral; financing need later

Management Commentary

“We are on schedule to report topline data by year-end 2025 from both the ACCESS and ACCESS II studies of aleniglipron…We believe the future of obesity treatment lies in multiple options and includes oral, combinable, and broadly accessible therapies—principles that define and differentiate our pipeline and development strategy.” — Raymond Stevens, Ph.D., CEO .
Timing clarity: “Both ACCESS and ACCESS II studies will read out at the same exact time at the end of the year, 36-week studies…We will be releasing…efficacy, tolerability, and safety data.” — Morgan Stanley fireside chat .
Regulatory environment: “No cardiovascular outcome study required…part of FDA’s update to address the obesity pandemic…phase III preparation work…underway.” — Morgan Stanley fireside chat .
Market view: “Primary care physicians…will prefer the oral pill approach…discontinuation rate for injectables ~50% after a year…patients are going to have options.” — Morgan Stanley fireside chat .

Q&A Highlights

Readout logistics and disclosure: Simultaneous ACCESS/ACCESS II topline at year-end; plan to release efficacy, tolerability, and safety in the press release .
Benchmarking: Cross-trial comparisons to orforglipron at 36 weeks; titration schemes and dose considerations discussed for efficacy and tolerability context .
FDA guidance: Phase 3 clarity, no CV outcomes required; placebo sizing and design challenges recognized across the field .
Combination strategy: Oral amylin as monotherapy with potential tolerability advantages; combinability with oral GLP-1 and other targets for enhanced weight loss; target profile is once-daily .

Estimates Context

Q3 2025 EPS: $-0.37 vs S&P Global consensus $-0.43 (12 estimates) — a beat.*
Revenue: Consensus $0.0, consistent with clinical-stage profile; actual $0.*
Prior quarters: Q1 EPS $-0.27 vs $-0.23 (9 estimates), Q2 EPS $-0.36 vs $-0.36 (9 estimates).*
Implication: Modest beats in Q1 and Q3 reflect higher net interest income offsetting opex ramp; consensus likely to remain anchored to spending cadence until topline efficacy readouts inform Phase 3 scope and financing.