Executive Summary

Q4 2024 remained pre-revenue with total revenue of $0.04M, while net loss narrowed to $11.0M (-$0.25 per share) from $20.2M (-$0.50) in Q4 2023 on materially lower R&D and G&A spend . EPS modestly beat third‑party consensus (-$0.25 vs. -$0.27), while revenue missed ($0.04M vs. $0.15M) per MarketBeat; S&P Global consensus data was unavailable at time of writing .
Cash, cash equivalents, and marketable securities were $65.5M at 12/31/24, guiding runway into 2H 2026, reflecting cost discipline despite pipeline progression .
RLYB212: Phase 2 trial dosing is underway (sentinel participant dosed in Feb 2025); PK/safety data expected in 2Q 2025 and at delivery in 3Q 2025—key 2025 catalysts .
RLYB116: “Best‑in‑class” potential reinforced by biomarker re‑characterization and manufacturing enhancements; confirmatory PK/PD study initiation targeted for 2Q 2025 with cohort readouts in 2H 2025—another near‑term catalyst .
Narrative for stock reaction focuses on 2025 clinical readouts (RLYB212 sentinel data; RLYB116 PK/PD confirmation) and cash runway sufficiency to reach those value inflections .

What Went Well and What Went Wrong

What Went Well

Cost discipline drove improved loss profile: Q4 R&D fell to $7.4M (from $15.9M YoY) and G&A to $4.3M (from $5.2M YoY), narrowing net loss to $11.0M from $20.2M in Q4 2023; management attributes decreases to lower program costs and workforce reduction effects .
RLYB212 execution: Regulatory approvals in Oct 2024 enabled screening in Nov; sentinel participant dosing occurred in Feb 2025, with PK/safety data expected in 2Q/3Q 2025—a clear line of sight to clinical proof steps in 2025 .
RLYB116 repositioned favorably: New analyses indicate prior assay overestimated free C5 (~10x), implying greater complement inhibition than first reported; along with purification improvements, supports once‑weekly SC profile and broader indication potential; confirmatory PK/PD study planned for 2Q 2025 .
Management tone: “We are pleased with our strong execution in 2024…laser focused on driving value for Rallybio in 2025” — Stephen Uden, CEO .

What Went Wrong

Minimal revenue: Collaboration/licensing revenue was only $0.04M for Q4 (and $0.64M for FY24), underscoring continued pre‑commercial status and dependence on external funding .
Continuing losses: Despite improvement, Q4 net loss remained sizeable at $11.0M; interest income also declined sequentially ($0.81M in Q4 vs. $0.99M in Q3), reflecting lower cash balances .
Ongoing development and financing risks: Company highlights uncertainties around clinical timelines, capital sufficiency, and competition in forward‑looking statements—key overhangs until readouts materialize .

Financial Results

Income Statement and Cash (YoY and Sequential)

Metric	Q4 2023	Q2 2024	Q3 2024	Q4 2024
Revenue ($M)	$0.00	$0.30	$0.30	$0.04
R&D Expense ($M)	$15.92	$12.95	$8.24	$7.39
G&A Expense ($M)	$5.19	$4.39	$4.13	$4.26
Net Loss ($M)	$(20.24)	$(16.24)	$(11.47)	$(11.04)
EPS (Basic & Diluted)	$(0.50)	$(0.37)	$(0.26)	$(0.25)
Cash & Marketable Securities ($M, period end)	$109.93 (12/31/23)	$88.61 (6/30/24)	$75.14 (9/30/24)	$65.51 (12/31/24)

Notes: All Q/Q figures are as reported; period-end cash aligns with the quarter end dates shown .

Q4 2024 Actuals vs. Consensus (Third‑Party Reference; S&P Global unavailable)

Metric	Q4 2024 Actual	Q4 2024 Consensus	Surprise
EPS	-$0.25	-$0.27	+$0.02
Revenue ($M)	$0.04	$0.15	-$0.11

Disclosure: S&P Global consensus estimates could not be retrieved due to API limit at time of analysis; third‑party figures shown for context.

KPIs and Operating Metrics

KPI	Q2 2024	Q3 2024	Q4 2024 / Early 2025
Pregnant women screened in FNAIT natural history study (cumulative)	>12,000 as of Aug 1, 2024	>13,000 as of Nov 1, 2024	>14,300 as of Jan 31, 2025
RLYB212 Phase 2 status	On track to initiate 4Q 2024	CTAs approved; screening to begin 4Q 2024	Sentinel participant dosed Feb 2025; PK/safety data expected 2Q/3Q 2025
RLYB116 program status	Manufacturing enhancements progressing; biomarker work ongoing	Manufacturing completed; deeper complement biomarker characterization	New biomarker analyses imply stronger inhibition; confirmatory PK/PD study planned 2Q 2025
Cash runway	Into mid‑2026	Into mid‑2026	Into 2H 2026

Segment reporting: Not applicable; Rallybio does not report revenue by segment in these periods .

Guidance Changes

Metric/Topic	Period	Previous Guidance	Current Guidance	Change
RLYB212 Phase 2 initiation/screening	4Q 2024	Screening to begin 4Q 2024	Screening initiated Nov 2024; sentinel dosed Feb 2025	Achieved and advanced
RLYB212 PK/safety readouts	2025	Not previously specified	PK/safety data: 2Q 2025 (2nd trimester), at delivery in 3Q 2025	New/added specificity
RLYB116 next steps	2024/2025	Update on mfg/biomarkers in Dec 2024	Confirmatory PK/PD study initiation in 2Q 2025; cohort readouts 2H 2025	Updated to defined 2025 clinical plan
Cash runway	Through 2026	Into mid‑2026 (as of 9/30/24)	Into 2H 2026 (as of 12/31/24)	Slightly extended

Earnings Call Themes & Trends

(Company did not provide an earnings call transcript in our document set; themes below reflect company releases across quarters.)

Topic	Previous Mentions (Q2 & Q3 2024)	Current Period (Q4 2024 release)	Trend
RLYB212 clinical execution	On track for 4Q 2024 screening; >12k screened; CTA approvals expected/received	Screening initiated Nov; sentinel dosed Feb; PK/safety readouts scheduled in 2025	Positive progression with defined 2025 readouts
RLYB116 assay/tolerability	Mfg enhancements progressing; biomarker work ongoing	New analyses imply stronger complement inhibition; mfg purification expected to improve tolerability; confirmatory PK/PD study planned 2Q 2025	Improving dataset; clarified 2025 plan
Cost discipline/runway	Refocused operating plan; reduced cash burn; cash $88.6M (6/30) then $75.1M (9/30), runway mid‑2026	Cash $65.5M (12/31); runway into 2H 2026	Runway maintained/slightly extended despite lower cash
External partnerships	J&J collaboration and equity investment noted	Revenue recognized tied to J&J collaboration obligations	Execution of collaboration
Pipeline breadth (ENPP1/iron overload)	ENPP1 candidate nomination by YE 2024; RLYB332 data planned	ENPP1 renamed REV102; IND‑enabling for 2026; RLYB332 preclinical data supportive	Continued preclinical progress

Management Commentary

“We are pleased with our strong execution in 2024, and look forward to reporting on our planned milestones in 2025…we are laser focused on driving value for Rallybio in 2025 and positioning the Company for sustained growth and success in the future.” — Stephen Uden, M.D., CEO .
“The initiation of screening in the RLYB212 Phase 2 trial is a significant milestone…We look forward to providing further updates on the trial’s progress upon dosing of the first participant.” — Stephen Uden, M.D., CEO (Nov 21, 2024) .
“Recently completed efforts…indicate that RLYB116 achieved greater complement inhibition in the Phase 1 study than initially reported…RLYB116 is expected to have a favorable tolerability profile…We look forward to bringing RLYB116 into a confirmatory clinical PK/PD study in the second quarter of 2025.” — Stephen Uden, M.D., CEO (Dec 2, 2024) .

Q&A Highlights

No earnings call transcript was available in our document set, and we could not locate a transcript to review. MarketBeat lists a conference call around the Q4 release (not independently corroborated with a transcript); therefore, no Q&A themes can be summarized .

Estimates Context

S&P Global consensus estimates were unavailable at the time of analysis due to API request limitations.
As a third‑party reference, MarketBeat shows Q4 2024 EPS of -$0.25 vs. -$0.27 consensus (+$0.02 beat) and revenue of $0.04M vs. $0.15M consensus (-$0.11M miss) .
Given limited revenue contribution and emphasis on 2025 clinical catalysts, we expect estimate revisions to focus less on near‑term revenue/EPS and more on operating expense trajectories and milestone timing for RLYB212/RLYB116 .

Key Takeaways for Investors

Cost curve inflecting: Q4 OpEx reductions drove a smaller net loss despite immaterial revenue; cash runway into 2H 2026 supports upcoming readouts without near‑term financing assumptions .
2025 catalyst path defined: RLYB212 PK/safety data from the sentinel participant in 2Q/3Q 2025; RLYB116 confirmatory PK/PD study initiation 2Q 2025 with 2H 2025 cohort readouts—events likely to drive stock moves .
RLYB116 upside re‑framed: Biomarker re‑characterization and manufacturing improvements may reposition RLYB116 as a competitive once‑weekly SC C5 inhibitor; confirmatory data will be critical .
Collaboration validation: Modest revenue recognition reflects J&J collaboration progress; strategic partnerships remain a lever for non‑dilutive funding and market access .
Risk balance: Continued net losses and clinical/regulatory uncertainties persist; execution on 2025 milestones is pivotal for valuation and funding optionality .
Near‑term trading lens: Expect sensitivity to any interim updates on RLYB212 sentinel participant PK/safety and RLYB116 confirmatory study start/time lines; cash runway commentary provides downside cushion barring unexpected delays .

Sources:

Q4 2024 8‑K and press release with financials and business updates .
Q3 2024 8‑K and press release .
Q2 2024 8‑K and press release .
Additional press releases (Oct–Dec 2024): CTA approvals for RLYB212 ; initiation of Phase 2 screening ; RLYB116 biomarker/manufacturing update and 2Q 2025 study plan ; ASH preclinical data for RLYB212 and RLYB332 .
Third‑party estimate snapshot (MarketBeat) .

Rallybio Corp (RLYB)·Q4 2024 Earnings Summary