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Rallybio Corp (RLYB)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was operationally on track and financially disciplined: dosing began in the RLYB116 confirmatory PK/PD study in June, data from Cohort 1 and Cohort 2 remain slated for 3Q25 and 4Q25, respectively, and the company refined its focus following the April discontinuation of RLYB212 .
  • EPS modestly beat consensus and revenue exceeded a de minimis Street expectation: EPS of $-0.22 vs $-0.24 consensus (beat by ~$0.02); revenue of $0.212M vs $0.0M consensus .
  • Balance sheet strengthened via portfolio action: sale of interest in REV102 to Recursion for up to $25M (including $7.5M upfront equity) extended cash runway to mid-2027, providing funding through key RLYB116 readouts .
  • The setup into 2H25 centers on RLYB116: management expects confirmatory PK/PD data to show complete and sustained complement inhibition with improved tolerability; initial indications prioritized for PTR and refractory APS .

What Went Well and What Went Wrong

What Went Well

  • RLYB116 execution: dosing in the confirmatory PK/PD study began in June, with topline data from Cohort 1 and 2 expected in 3Q25 and 4Q25, respectively, and an expectation of complete and sustained complement inhibition with improved tolerability .
  • Portfolio monetization and runway: divestiture of interest in REV102 (up to $25M consideration, $7.5M upfront equity) extended runway to mid-2027, reducing financing overhang through pivotal RLYB116 milestones .
  • Cost discipline and YoY P&L improvement: R&D down to $6.1M from $12.9M YoY and G&A slightly down to $4.2M from $4.4M YoY; net loss improved to $9.7M from $16.2M YoY .

What Went Wrong

  • Program setback: RLYB212 discontinued in April after Phase 2 PK data failed to achieve target concentrations; removes a near-term maternal-fetal health catalyst and concentrates risk on RLYB116 .
  • Sequential cash draw: cash, cash equivalents, and marketable securities declined to $45.7M at 6/30/25 from $54.5M at 3/31/25 ahead of the REV102 upfront receipt in July .
  • Limited top-line contribution: revenue remained immaterial at $0.212M, reflecting limited external revenues tied primarily to J&J collaboration recognition timing .

Financial Results

Summary P&L (oldest → newest)

MetricQ2 2024Q1 2025Q2 2025
Revenue ($USD Millions)$0.299 $0.212 $0.212
Net Loss ($USD Millions)$(16.236) $(9.439) $(9.703)
Diluted EPS ($)$(0.37) $(0.21) $(0.22)
Net Income Margin %(5,425%) (4,452%) (4,579%)

Operating Expenses (oldest → newest)

Metric ($USD Millions)Q2 2024Q1 2025Q2 2025
R&D$12.946 $5.725 $6.074
G&A$4.388 $4.157 $4.195
Total Opex$17.334 $9.882 $10.269

Balance Sheet KPIs

KPIQ2 2024Q1 2025Q2 2025
Cash, Cash Equivalents & Marketable Securities ($USD Millions)—$54.495 $45.749
Weighted Avg. Shares (Basic & Diluted)44.128M 44.775M 44.841M

Estimate Comparison (Q2 2025)

MetricConsensus*ActualDelta
EPS ($)-0.24*-0.22 +$0.02 vs cons*
Revenue ($USD Millions)$0.00*$0.212 +$0.212 vs cons*

Values marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayMulti-yearInto 1H 2027 (as of 3/31/25) Into mid-2027 (post-REV102 upfront) Raised/extended (timing refined)
RLYB116 confirmatory PK/PD – Cohort 1 data3Q 2025Expected 3Q 2025 Expected 3Q 2025 (affirmed) Maintained
RLYB116 confirmatory PK/PD – Cohort 2 data4Q 2025Expected 4Q 2025 Expected 4Q 2025 (affirmed) Maintained
RLYB116 initial indication focus—Broad complement opportunity incl. PNH, gMG, APS (exploratory) Initial focus on PTR and refractory APS Sharpened/clarified
REV102 program—JV with Recursion; IND-enabling studies to support 2026 start Interest sold to Recursion; up to $25M consideration, $7.5M upfront Monetized asset
RLYB212 program—Phase 2 underway with sentinel; data in 2Q/3Q 2025 Program discontinued (April 2025) Lowered/terminated

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
R&D execution (RLYB116)Plan to start confirmatory PK/PD in 2Q25 with 2H25 readouts Dosing initiated in June; Cohort 1/2 readouts on track for 3Q/4Q25 Positive execution momentum
Regulatory/clinical (RLYB212)Sentinel dosed; interim PK/safety planned 2Q/3Q25 Program discontinued on PK target shortfall Negative; risk concentrated on RLYB116
Cash/financing$65.5M YE24; runway into 2H26 $45.7M at 6/30; REV102 sale extends runway to mid-2027 Improved duration post-transaction
Portfolio strategyMulti-asset (RLYB212/116/REV102/332) Sharpened focus: monetize REV102; prioritize RLYB116; continue RLYB332 assessment Focused/streamlined
Technology/AINot emphasizedRecursion highlights AI platform in REV102 context External partner-driven; limited direct impact
Macro/supply chain/tariffsNot emphasizedNot discussed in Q2 press materials Stable/Not discussed

Management Commentary

  • “The second quarter marked a pivotal step forward as we advanced our lead program, RLYB116, into a confirmatory PK/PD study... strategic divestiture of a preclinical asset underscores our commitment to disciplined portfolio management... build long-term value for shareholders.” — Stephen Uden, M.D., CEO .
  • “We look forward to the advancement of REV102 through key milestones... For Rallybio, divesting this preclinical asset enables us to extend our cash runway while sharpening our focus on strategically advancing our pipeline.” — Stephen Uden, M.D., CEO .
  • RLYB116 initial focus clarified to PTR and refractory APS; confirmatory study expected to demonstrate complete and sustained complement inhibition with improved tolerability .

Q&A Highlights

  • No Q&A content was disclosed in the company’s Q2 materials reviewed; analysis is based on the 8-K/press releases .

Estimates Context

  • EPS: Actual $-0.22 vs consensus $-0.24* (beat by ~$0.02*); small upside reflects tighter opex and lower YoY R&D/G&A .
  • Revenue: Actual $0.212M vs $0.0M* consensus (beat by $0.212M*), but absolute revenue remains de minimis and driven by collaboration revenue recognition timing .
    Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term catalyst path is clear: RLYB116 confirmatory PK/PD topline from Cohort 1 in 3Q25 and Cohort 2 in 4Q25; demonstration of sustained complement inhibition and improved tolerability would be thesis-affirming .
  • Balance sheet runway into mid-2027 following the REV102 transaction reduces financing risk through both RLYB116 data readouts and potential indication selection activities .
  • Portfolio rationalization (RLYB212 discontinued; REV102 monetized) concentrates value and risk on RLYB116; execution on dosing, tolerability, and PK/PD endpoints is pivotal for stock direction into 2H25/early 2026 .
  • Cost base reset YoY supports operating leverage if/when RLYB116 advances; YoY opex reductions translated into a materially narrower net loss .
  • Indication strategy refined toward hematologic settings (PTR, refractory APS), potentially enabling focused development pathways and differentiated positioning versus incumbent complement inhibitors .
  • Collaboration revenue remains minimal; stock reaction will be driven primarily by clinical readouts and capital runway dynamics rather than near-term P&L .

Appendix: Source Documents

  • Q2 2025 Form 8-K and Exhibit 99.1 press release: financials, program updates, cash runway .
  • Q2 2025 press release (Business Wire): financials, RLYB116 timing, cash runway .
  • REV102 sale press release (July 8, 2025): transaction details and runway extension .
  • Q1 2025 press release: prior-quarter comparatives and guidance baseline .
  • Q4/FY 2024 press release: two-quarters-prior baseline .