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Rallybio Corp (RLYB)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 delivered a narrower net loss on sharply lower OpEx and modest collaboration revenue recognition; EPS of -$0.21 beat S&P Global consensus of -$0.26, and revenue of $0.21M beat a street expectation of $0.00M, both modest but directionally positive . Results vs consensus from S&P Global*.
  • Strategic pivot: RLYB212 was discontinued after Phase 2 PK failed to achieve target concentrations; management is refocusing on RLYB116 (C5 inhibitor) and preclinical assets REV102 and RLYB332 .
  • RLYB116 confirmatory PK/PD study remains on track to initiate dosing in 2Q 2025, with Cohort 1 data expected in Q3 2025 and Cohort 2 in Q4 2025—key catalysts for 2H 2025 .
  • Cash, cash equivalents and marketable securities were $54.5M (runway into 1H 2027), extended from 2H 2026 at year-end, aided by cost discipline and workforce reduction .

What Went Well and What Went Wrong

What Went Well

  • EPS beat and lower burn: Net loss improved to -$9.4M vs -$19.0M y/y, driven by reduced R&D and G&A; EPS -$0.21 beat consensus (-$0.26) by $0.05* . Results vs consensus from S&P Global*.
  • Operational focus: Management reiterated confidence in RLYB116 as potentially best-in-class, highlighting planned confirmatory PK/PD dosing in 2Q and biomarker data indicating sustained complement inhibition potential .
  • Extended runway: Cash of $54.5M supports operations into 1H 2027, providing execution runway through multiple data readouts (RLYB116 cohorts and REV102 preclinical) .

“Leveraging our team’s deep expertise in the complement field, we are well-positioned to maximize RLYB116’s transformative potential across multiple billion-dollar market opportunities.” — CEO Stephen Uden, M.D.

What Went Wrong

  • Program discontinuation: RLYB212 Phase 2 PK results were outside predicted range and below minimum target concentration for efficacy; program discontinued—a material setback to the maternal-fetal health franchise .
  • Revenue base remains immaterial: Collaboration revenue recognized ($0.212M) is small; margins are not meaningful given negligible top line .
  • Workforce reduction: 40% workforce cut (~9 positions) to align costs with pipeline focus; ~$1.7M in charges—needed for runway extension but reflects contraction following program discontinuation .

“We are disappointed by the PK results of the RLYB212 Phase 2 trial… the risk/benefit no longer supports continued dosing, and we will discontinue RLYB212 development.” — CEO Stephen Uden, M.D.

Financial Results

Quarterly Trend (Sequential: Q3 2024 → Q4 2024 → Q1 2025)

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$0.299 $0.038 $0.212
Net Loss ($USD Millions)$(11.466) $(11.044) $(9.439)
EPS (Basic & Diluted, $USD)$(0.26) $(0.25) $(0.21)
R&D Expense ($USD Millions)$8.240 $7.385 $5.725
G&A Expense ($USD Millions)$4.125 $4.261 $4.157
Loss from Operations ($USD Millions)$(12.066) $(11.608) $(9.670)
Interest Income ($USD Millions)$0.986 $0.811 $0.644
Weighted Avg. Shares (Millions)44.593 44.661 44.775

Year-over-Year Comparison (Q1 2024 → Q1 2025)

MetricQ1 2024Q1 2025
Revenue ($USD Millions)$0.000 $0.212
Net Loss ($USD Millions)$(19.029) $(9.439)
EPS (Basic & Diluted, $USD)$(0.47) $(0.21)
R&D Expense ($USD Millions)$12.936 $5.725
G&A Expense ($USD Millions)$6.851 $4.157
Total Operating Expenses ($USD Millions)$19.787 $9.882

Margins (Note: not meaningful due to immaterial revenue base)

MetricQ3 2024Q4 2024Q1 2025
Net Income Margin %N/M (revenue immaterial) N/M (revenue immaterial) N/M (revenue immaterial)
EBIT (Loss from Operations) Margin %N/M (revenue immaterial) N/M (revenue immaterial) N/M (revenue immaterial)

Revenue Breakdown (Q1 2025)

Revenue TypeQ1 2025
Collaboration and License ($USD Millions)$0.212

Cash and Balance Sheet

MetricQ3 2024Q4 2024Q1 2025
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$75.139 $65.511 $54.495
Total Assets ($USD Millions)$79.007 $68.108 $57.983
Total Liabilities ($USD Millions)$8.189 $6.454 $3.910
Stockholders’ Equity ($USD Millions)$70.818 $61.654 $54.073

Q1 2025 Actual vs S&P Global Consensus

MetricConsensus Q1 2025Actual Q1 2025Surprise
Revenue ($USD Millions)$0.000*$0.212 +$0.212M (Beat)*
EPS (Basic & Diluted, $USD)-$0.26*-$0.21 +$0.05 (Beat)*

Values retrieved from S&P Global*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporateInto 2H 2026 Into 1H 2027 Raised (extended)
RLYB116 Confirmatory PK/PD2025Initiate in 2Q 2025; data in 2H 2025 On track to initiate dosing in 2Q 2025; Cohort 1 data Q3 2025, Cohort 2 Q4 2025 Maintained/Specified
RLYB212 Program2025Sentinel dosed; PK/safety data expected Q2/Q3 2025 Program discontinued due to sub-target PK Lowered (discontinued)
Workforce Reduction2025Not specified previously (not quantified) 40% reduction (~9 roles), ~$1.7M charges New
REV102 (ENPP1)2025–2026IND-enabling underway; Phase 1 in 2026 IND-enabling to support Phase 1 initiation in 2H 2026; preclinical data 2H 2025 Clarified timing
RLYB3322025Favorable PD vs comparators; planning future dev Continuing to evaluate plans; best-in-class potential reiterated Maintained

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was found in our source set; themes reflect company disclosures from press releases.

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
RLYB116 (C5 inhibitor)Manufacturing enhancements; biomarker work indicates greater sustained free C5 reductions; December update planned Biomarker analyses suggest broader disease applicability (PNH, gMG, APS); confirmatory PK/PD planned for 2Q 2025 On track to initiate confirmatory PK/PD dosing 2Q; Cohort 1/2 data in Q3/Q4; best-in-class potential emphasized Positive execution; 2H data catalysts
RLYB212 (FNAIT)CTA approvals; screening to begin 4Q 2024; natural history >13,000 screened Sentinel dosed Feb; PK/safety data expected Q2/Q3 2025 Program discontinued after sentinel PK below targets Negative; franchise curtailed
REV102 (ENPP1)Candidate nomination with partner expected Dec; preclinical efficacy in HPP mice IND-enabling underway; Phase 1 targeted 2026 IND-enabling ongoing; Phase 1 initiation targeted 2H 2026; preclinical data presentation 2H 2025 Steady progress
RLYB332 (anti-matriptase-2)Nonclinical data at ASH; long-acting potential for iron overload diseases PD impact superior vs comparators; supports best-in-class profile Continuing to evaluate plans; PD superiority reaffirmed Advancing planning
Corporate/OpEx disciplineRefocused operating plan; reduced burn Continued discipline; runway into 2H 2026 40% workforce reduction; runway into 1H 2027 Enhanced runway

Management Commentary

  • Strategic focus: “We are focused on advancing RLYB116 into a confirmatory pharmacokinetic/pharmacodynamic study this quarter, and believe that data from this study will demonstrate RLYB116’s potential to be a best-in-class therapeutic for patients with complement-driven diseases.” — CEO Stephen Uden, M.D.
  • Pipeline value: “We believe significant value resides within our preclinical pipeline, which includes REV102 and RLYB332.” — CEO Stephen Uden, M.D.
  • RLYB212 discontinuation: “Given that the results significantly deviated from the predicted range and the absence of empiric data to further inform dose adjustment, the risk/benefit no longer supports continued dosing, and we will discontinue RLYB212 development.” — CEO Stephen Uden, M.D.

Q&A Highlights

  • No Q1 2025 earnings call transcript was available in our document set; therefore, no analyst Q&A themes or clarifications can be cited from an earnings call transcript [ListDocuments returned none for earnings-call-transcript].

Estimates Context

  • Q1 2025 EPS: -$0.21 vs consensus -$0.26; beat by $0.05 driven by reduced R&D and G&A and modest collaboration revenue recognition* .
  • Q1 2025 Revenue: $0.212M vs consensus $0.000M; beat on collaboration revenue recognition from the J&J agreement* .
  • Coverage breadth: # of estimates — EPS: 3; Revenue: 3 for Q1 2025*. Values retrieved from S&P Global*

Key Takeaways for Investors

  • The RLYB212 discontinuation is a material setback, but it clarifies capital allocation toward RLYB116 and preclinical assets; near-term narrative pivots to complement therapeutics .
  • RLYB116 confirmatory PK/PD dosing in 2Q and cohort data in Q3/Q4 are the principal 2025 catalysts; execution there will drive valuation and partnership optionality .
  • OpEx discipline materially lowered burn, enabling an extended runway into 1H 2027—even after charges tied to workforce reduction; reduces near-term financing pressure .
  • Modest collaboration revenue recognition aided results but remains immaterial; valuation will hinge more on clinical milestones than near-term P&L scaling .
  • Watch REV102 preclinical data in 2H 2025 and Phase 1 initiation in 2H 2026 for optionality in HPP; RLYB332 remains a potential best-in-class iron overload therapy with superior PD signals .
  • Short-term trading: Shares likely to react around RLYB116 dosing start and interim data windows; any tolerability or PD signals consistent with sustained complement inhibition are positive de-risking events .
  • Medium-term thesis: A successful RLYB116 profile could position Rallybio in significant complement markets (PNH/gMG/APS) with a potentially convenient, once-weekly SC approach; partnering or financing terms will depend on 2H 2025 data quality .
Sources:
- Q1 2025 results press release and financial tables **[1739410_a70e55bf0d064f5ea822aa1e771599a5_0]** **[1739410_a70e55bf0d064f5ea822aa1e771599a5_1]** **[1739410_a70e55bf0d064f5ea822aa1e771599a5_5]**
- Q1 2025 8-K and Exhibit 99.1 (Item 2.02) **[1739410_0001739410-25-000059_rlyb-20250508.htm:1]** **[1739410_0001739410-25-000059_rlyb-2025058xex991pressrel.htm:0]** **[1739410_0001739410-25-000059_rlyb-2025058xex991pressrel.htm:1]** **[1739410_0001739410-25-000059_rlyb-2025058xex991pressrel.htm:3]**
- RLYB212 discontinuation (Apr 8, 2025) **[1739410_1929539237d54559abcebe0bad10247b_0]** **[1739410_1929539237d54559abcebe0bad10247b_1]**
- RLYB212 Phase 2 dosing initiation (Feb 11, 2025) **[1739410_329d263f20694e5e91bd8f0d12975149_0]**
- Q4/FY 2024 results press release **[1739410_baa0c39ddecb45e097a3084d37f1d119_0]** **[1739410_baa0c39ddecb45e097a3084d37f1d119_1]** **[1739410_baa0c39ddecb45e097a3084d37f1d119_2]** **[1739410_baa0c39ddecb45e097a3084d37f1d119_4]**
- Q3 2024 results press release **[1739410_618e75e65ac6459a93cee6a577cd76ef_0]** **[1739410_618e75e65ac6459a93cee6a577cd76ef_1]** **[1739410_618e75e65ac6459a93cee6a577cd76ef_2]** **[1739410_618e75e65ac6459a93cee6a577cd76ef_3]** **[1739410_618e75e65ac6459a93cee6a577cd76ef_6]**
- Estimates: S&P Global* (GetEstimates for Q1 2025: EPS, Revenue, # of estimates)