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ASSEMBLY BIOSCIENCES, INC. (ASMB)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 delivered collaboration revenue of $9.63M, up 12.8% year over year (vs. $8.53M) and roughly flat sequentially (vs. $9.42M in Q1) as Gilead-funded R&D increased; net loss narrowed to $10.2M with EPS of -$1.33 .
  • Results vs consensuses: Revenue was a clear beat at $9.63M vs $5.30M estimate; EPS missed at -$1.33 vs -$1.19 estimate. Bolded below. Values retrieved from S&P Global.*
  • Cash, cash equivalents and marketable securities declined to $75.0M, with runway maintained into mid-2026; subsequent events include positive ABI-5366 interim Phase 1b data (94% shedding reduction; 94% lesion rate reduction) and a $175M equity/warrants financing with Gilead’s participation .
  • Narrative catalysts: Strong HSV program interim data and HBV CAM ABI-4334 topline (3.2 log10 HBV DNA decline at 400 mg) support pipeline momentum; timeline for genital herpes PoC shifted later to “no later than fall” vs prior H1 target .

What Went Well and What Went Wrong

What Went Well

  • Collaboration revenue growth and operating discipline: Q2 revenue rose to $9.63M (+$1.09M YoY) with R&D essentially flat YoY ($16.1M vs $16.3M) and G&A stable ($4.6M vs $4.5M), narrowing net loss to $10.2M from $11.2M YoY .
  • HSV program efficacy outperformed targets: ABI-5366 350 mg weekly cut HSV-2 shedding rate by 94% (p<0.01), high viral load shedding by 98% (p<0.05), and genital lesion rate by 94% (p<0.01), exceeding the 80–85% shedding reduction target; PK supports weekly/monthly dosing .
  • HBV program met clinical profile: ABI-4334 showed mean HBV DNA declines of 3.2 log10 IU/mL (400 mg) and 2.9 log10 IU/mL (150 mg) over 28 days with favorable safety, reaching exposures consistent with engaging replication inhibition and targeting cccDNA formation .
  • CEO tone on execution: “We are advancing toward our goal of generating impactful clinical datasets for four development candidates in 2025…” .

What Went Wrong

  • EPS missed consensus: Q2 EPS -$1.33 vs -$1.19 consensus. Values retrieved from S&P Global.*
  • Cash draw and equity dilution risk: Cash, cash equivalents and marketable securities fell to $75.0M from $91.0M in Q1, and shareholders’ equity declined to $18.1M from $27.1M; subsequent $175M financing adds dilution despite strategic participation (including Gilead) .
  • HDV entry inhibitor safety signals to monitor: ABI-6250 Phase 1a saw grade 2 ALT elevation at highest single dose and low-frequency grade 1 elevations; off-target CP-1 elevation noted at 25 mg, prompting further pharmacologic assessment before Phase 2 .

Financial Results

Income Statement (USD)

MetricQ2 2024Q1 2025Q2 2025
Collaboration Revenue ($)$8,533,000 $9,419,000 $9,626,000
Research & Development ($)$16,259,000 $14,851,000 $16,125,000
General & Administrative ($)$4,477,000 $4,509,000 $4,594,000
Net Loss ($)$(11,152,000) $(8,818,000) $(10,198,000)
EPS (basic & diluted) ($)$(1.98) $(1.17) $(1.33)

Balance Sheet and Liquidity

MetricDec 31, 2024Mar 31, 2025Jun 30, 2025
Cash, Cash Equivalents & Marketable Securities ($)$112,079,000 $91,028,000 $75,0​00,000
Cash & Cash Equivalents ($)$38,344,000 $23,413,000 $24,006,000
Marketable Securities ($)$73,735,000 $67,615,000 $50,974,000
Deferred Revenue (short-term) ($)$37,622,000 $40,819,000 $40,917,000
Stockholders’ Equity ($)$33,359,000 $27,133,000 $18,100,000
Cash RunwayMid-2026 Mid-2026 Mid-2026

Revenue Composition

Revenue ComponentQ2 2024Q1 2025Q2 2025
Collaboration Revenue from Related Party ($)$8,533,000 $9,419,000 $9,626,000

Clinical KPIs (ABI-5366 Phase 1b Interim)

MetricPlacebo150/30 mg Weekly350 mg Weekly
HSV-2 Shedding Rate (%)14.6% 14.5% 0.9%
High Viral Load Shedding Rate (%)11.4% 9.4% 0.2%
Genital Lesion Rate (%)19.7% 11.8% 1.3%
Mean Duration of Viral Shedding (days)5.8 3.6 1.8
Mean Duration of Genital Lesions (days)6.3 5.7 1.8

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporateFunded into mid-2026 Funded into mid-2026 Maintained
ABI-5366/ABI-1179 Phase 1b PoC (genital herpes)ClinicalInterim data expected H1 2025 Interim data “no later than fall 2025” Lowered (timeline shifted later)
ABI-4334 Phase 1b (HBV)ClinicalInterim data by end of 2024 Topline data reported; opt-in review by Gilead Achieved; Opt-in decision point triggered
ABI-6250 Phase 1a (HDV)ClinicalData in Q3 2025; target engagement biomarker to be assessed Interim data including NTCP biomarker; further pharmacology before Phase 2 Expanded characterization; Phase 2 prep continues

Earnings Call Themes & Trends

Earnings call transcript not available for Q2 2025; themes tracked from company disclosures.

TopicPrevious Mentions (Q4 2024 & Q1 2025)Current Period (Q2 2025)Trend
R&D ExecutionPositive interim for ABI-5366; initiation of ABI-1179/6250 planned ABI-5366 superior interim outcomes; ABI-1179 Phase 1b dosing initiated; ABI-6250 interim biomarker data Strengthening
HBV Capsid Modulator (ABI-4334)Interim expected by end-2024 Topline efficacy/safety achieved; exposures supportive of replication and cccDNA inhibition; opt-in point Strengthening
HSV Program DosingLong half-life supports weekly/monthly Once-weekly efficacy; monthly cohort ongoing; Phase 2 planned mid-2026 Strengthening
Collaboration with GileadEquity and accelerated funding received IND clearance for ABI-1179 expansion in U.S.; potential opt-in on programs Maintained/Active
Financing—$175M equity/warrants offering with blue-chip participation; Gilead participates Strengthening liquidity
HDV Entry Inhibitor (ABI-6250)Phase 1a initiation NTCP engagement biomarker; ALT elevations under assessment; Phase 2 prep Mixed (progress with monitored safety)

Management Commentary

  • CEO Jason Okazaki: “We are advancing toward our goal of generating impactful clinical datasets for four development candidates in 2025… Looking ahead, we remain on track to report key proof-of-concept Phase 1b data…” .
  • CMO Anuj Gaggar on ABI-5366: “We are thrilled to see these interim data for ABI-5366 far exceeding the targets we had set…” .
  • CMO Anuj Gaggar on ABI-6250: “We are encouraged by the observed half-life supportive of once-daily oral dosing and bile acid elevations indicative of NTCP target engagement…” .
  • CMO Anuj Gaggar on ABI-4334: “These data support the ability of ABI-4334 to effectively inhibit viral replication at the lower 150 mg dose, while offering the potential to dose higher for purposes of maximizing inhibition of cccDNA formation.” .

Q&A Highlights

Earnings call transcript was not found for Q2 2025; Q&A details unavailable. Company disclosures emphasize HSV/HDV/HBV clinical progress, financing, and collaboration milestones .

Estimates Context

MetricQ2 2025 Estimate*Q2 2025 Actual*Outcome
Revenue ($)$5.30M*$9.63M*Beat
EPS ($)-$1.19*-$1.33*Miss
# of EPS Estimates1*——
# of Revenue Estimates2*——

Values retrieved from S&P Global.*
Note: Actuals are also presented with citations in the Financial Results section .

Key Takeaways for Investors

  • Revenue beat and EPS miss: Collaboration revenue outpaced consensus; EPS lagged due to continued R&D investment tempo and limited operating leverage in current clinical stage . Values retrieved from S&P Global.*
  • HSV program is a near-term catalyst: ABI-5366 delivered statistically robust antiviral and clinical outcomes vs placebo; Phase 1b monthly cohort ongoing and Phase 2 targeted mid-2026 .
  • HBV CAM delivers consistent potency: ABI-4334 achieved 2.9–3.2 log10 HBV DNA declines over 28 days with favorable safety; Gilead opt-in decision point created a strategic option value .
  • HDV entry inhibitor progressing with guardrails: NTCP biomarker engagement and PK support daily oral dosing; monitor ALT elevations and off-target CP-1 signals before Phase 2 .
  • Liquidity bolstered post-quarter: Despite Q2 cash draw to $75.0M and equity decline, the $175M financing and Gilead participation extend strategic runway; corporate guidance remains funded into mid-2026 .
  • Timeline adjustments: Genital herpes interim PoC shifted from H1 2025 to “no later than fall 2025”; still a 2025 dataset, but later than earlier expectations .
  • Trading implications: Positive HSV and HBV data flow and financing de-risk near-term execution; watch for fall HSV interim data, Gilead option decisions, and any further ABI-6250 safety characterization .