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Rallybio Corp (RLYB)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 printed a headline EPS of $0.36 driven by $22.5M “Gain on sale of joint venture and other income,” producing net income of $16.0M despite minimal revenue of $0.21M; the beat vs consensus EPS -$0.21* and revenue $0.07M* was material and largely non-recurring .
  • Corporate actions strengthened liquidity: $20M received from Recursion ($7.5M upfront equity + $12.5M milestone) extended cash runway to 2027; quarter-end cash, cash equivalents, and marketable securities were $59.3M .
  • RLYB116 execution advanced: Cohort 1 dosing completion and continued progress toward 4Q 2025 data; note timing shift from prior guidance (Cohort 1 readout moved from 3Q to 4Q 2025) .
  • Narrative drivers: non-dilutive capital, portfolio focus on complement-dysregulation, and upcoming RLYB116 PK/PD readouts; watch for confirmation of complete/sustained complement inhibition and tolerability in Cohort 1/2 data .

Values with * are retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well

  • Non-dilutive capital strengthened balance sheet: $20M from Recursion (upfront $7.5M equity and $12.5M milestone) and runway extended through 2027 .
  • RLYB116 progressed: Cohort 1 dosing completed; management reaffirmed confidence in efficacy and differentiation, aiming for hematologic indications PTR and refractory APS. CEO: “we remain on track to report data in the fourth quarter of 2025 and are increasingly confident in RLYB116's potential to be an effective therapeutic” .
  • Expense discipline: R&D and G&A fell meaningfully YoY due to program reprioritization (RLYB212 discontinuation) and workforce actions, improving operating loss vs prior year .

What Went Wrong

  • Timing slippage: prior guidance targeted Cohort 1 data in 3Q 2025, now expected 4Q 2025; investors should watch for whether Cohort 2 remains on schedule .
  • Revenue softness: collaboration revenue declined YoY (Q3 2025 $0.21M vs $0.30M), reflecting prior-year J&J collaboration recognition; continued minimal top-line constrains traditional margin analysis .
  • Headline profitability driven by one-time other income (JV sale); core operating loss persisted (-$6.9M in Q3), underscoring dependence on external funding and milestones pre-clinical readouts .

Financial Results

Quarterly Performance vs Prior Periods

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$0.299 $0.212 $0.212 $0.212
Net Income ($USD Millions)-$11.466 -$9.439 -$9.703 $16.016
Diluted EPS ($USD)-$0.26 -$0.21 -$0.22 $0.36
Operating Income ($USD Millions)-$12.066 -$9.670 -$10.057 -$6.925
Total Operating Expenses ($USD Millions)$12.365 $9.882 $10.269 $7.137
Cash, Cash Equivalents & Marketable Securities ($USD Millions)N/A$54.495 $45.749 $59.319

KPI Detail

KPIQ3 2024Q1 2025Q2 2025Q3 2025
R&D Expense ($USD Millions)$8.240 $5.725 $6.074 $4.143
G&A Expense ($USD Millions)$4.125 $4.157 $4.195 $2.994
Interest Income ($USD Millions)$0.986 $0.644 $0.523 $0.462
Gain on sale of JV & Other Income ($USD Millions)$0.251 $0.174 $0.118 $22.479
Weighted Avg Shares (Basic & Diluted)44,593,221 44,774,602 44,841,140 45,058,591

Q3 2025 Actuals vs Wall Street Consensus (S&P Global)

MetricConsensusActualSurprise
Revenue ($USD Millions)$0.067*$0.212 $0.145M beat
Primary EPS ($USD)-$0.21*$0.36 $0.57 beat (driven by JV sale gain)

Values with * are retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RLYB116 PK/PD Cohort 1 topline2H 20253Q 2025 data expected 4Q 2025 data expected Lowered (timing slip)
RLYB116 PK/PD Cohort 2 topline2H 20254Q 2025 data expected 4Q 2025 (unchanged) Maintained
Indication focus (PTR, refractory APS)OngoingAnnounced focus (Jun-2025) Reiterated focus Maintained
Cash runwayMulti-yearInto mid-2027 Through 2027 Raised (extended)
REV102 monetizationNear-termUp to $25M deal announced (Jul-2025) $20M received in Q3 ($7.5M upfront equity + $12.5M milestone) Executed milestones

Earnings Call Themes & Trends

(Full Q3 2025 call transcript not available; themes derived from press releases and filings.)

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
RLYB116 execution (PK/PD)Plan to initiate dosing in 2Q; Cohort 1/2 data in 3Q/4Q Dosing initiated; Cohort 1/2 data timeline reaffirmed Cohort 1 dosing completed; data now in 4Q; confidence reiterated Slight delay but progressing
Indication strategy (PTR, APS)Focus outlined Reiterated Reiterated Stable
Portfolio optimization / BDWorkforce reduction; pipeline reprioritization REV102 sale up to $25M $20M received; non-dilutive capital Strengthening balance sheet
Cost disciplineLower R&D/G&A YoY Continued OpEx reductions Further OpEx reductions Improving
Liquidity / runwayInto 1H 2027 Mid-2027 Through 2027 Improving

Management Commentary

  • CEO focus on disciplined execution and confidence in RLYB116: “we remain on track to report data in the fourth quarter of 2025 and are increasingly confident in RLYB116's potential to be an effective therapeutic” .
  • Strategic capital allocation: monetization of REV102 interest delivered $20M in Q3, providing non-dilutive support for development priorities .
  • R&D prioritization: continued emphasis on complement-mediated hematologic conditions; Cohort 1 data intended to demonstrate complete/sustained terminal complement inhibition with favorable tolerability .

Q&A Highlights

  • The Q3 2025 earnings call transcript was not available via our document tools or IR site at the time of analysis; no Q&A content to report (search returned no transcript documents) .

Estimates Context

  • Rallybio materially beat Street EPS and revenue in Q3 2025, but the beat was driven by the $22.5M gain on JV sale rather than operating performance; core revenue remained ~$0.21M .
  • Consensus EPS was -$0.21* vs actual $0.36; consensus revenue was $0.067M* vs actual $0.212M. Expect models to adjust for non-recurring other income and maintain focus on RLYB116 clinical milestones rather than near-term revenue.

Values retrieved from S&P Global.

Key Takeaways for Investors

  • Headline profitability is not reflective of recurring operations; the JV sale gain produced the EPS beat—monitor sustainability of cash runway and upcoming clinical catalysts, not GAAP EPS momentum .
  • RLYB116 remains the core value driver; Cohort 1 readout shifted to 4Q 2025—near-term stock reaction likely tied to strength of PD/PK and tolerability signals .
  • Balance sheet improved without dilution; $59.3M cash, equivalents & marketable securities and runway through 2027 reduce immediate financing overhang, enhancing optionality for BD or trial expansion .
  • Expense discipline is evident; continued R&D/G&A reductions tighten operating loss, but revenue remains minimal—expect valuation to be catalyst-driven rather than fundamentals-driven until pivotal clinical data .
  • Watch Recursion milestones around REV102 for any additional proceeds and potential read-through to non-dilutive funding capacity .
  • Risk factors: timing risk on PK/PD data, competitive C5 landscape, and need for robust tolerability to differentiate—position sizing should reflect binary catalyst risk .

Appendix: Additional Q3-Related Company Communications

  • Rallybio completes dosing of first cohort in RLYB116 PK/PD study (Sep 25, 2025) .
  • Rallybio receives $12.5M equity milestone payment from Recursion for REV102 (Sep 3, 2025) .