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BeyondSpring Inc. (BYSI)·Q4 2024 Earnings Summary

Executive Summary

  • BeyondSpring reported full-year 2024 results; the company does not disclose quarterly breakouts, so Q4 2024 financials are not separately provided. FY 2024 continuing-ops net loss narrowed to $8.9M vs. $14.0M in 2023, with R&D down to $2.6M and G&A down to $6.1M; cash was $2.9M at year-end .
  • Clinical execution advanced: DUBLIN-3 Phase 3 was published in The Lancet Respiratory Medicine showing OS/PFS/ORR benefits vs. docetaxel, and Phase 2 Study 303 updated results showed 21.1% ORR and 8.6-month median PFS in NSCLC patients resistant to prior PD-1/L1 therapy .
  • SEED Therapeutics momentum: a new Eisai collaboration (up to $1.5B potential payments), Series A-3 first close of $24M, and FDA rare pediatric disease and orphan designations for the RBM39 degrader; BeyondSpring also announced sale of a portion of SEED shares for $35.4M to fund Plinabulin development .
  • Near-term catalysts include NMPA submission planning for Plinabulin (NSCLC) and 2025 milestones across Plinabulin and SEED’s RBM39 program; stock narrative hinges on regulatory traction, Study 303/302 readouts, and liquidity actions .

What Went Well and What Went Wrong

What Went Well

  • Plinabulin’s DUBLIN-3 Phase 3 final data showed statistically significant OS, PFS, and ORR benefits vs. docetaxel and substantially reduced grade 4 neutropenia; the study was published in The Lancet Respiratory Medicine .
  • Study 303 updated Phase 2 data (n=30) demonstrated 21.1% ORR, 8.6-month mPFS, and 89.3% disease control rate in metastatic NSCLC patients progressed on prior PD-1/L1 inhibitors, with tolerable safety profile (“no treatment-related deaths”) .
  • Management emphasized strengthened regulatory strategy and confidence: “This Phase 3 data… strengthens our regulatory strategy as we prepare for submission to the NMPA” — Dr. Lan Huang .

What Went Wrong

  • No product revenue reported in FY 2024; BeyondSpring remains in clinical stage, with continuing-ops net loss of $8.9M and a total shareholders’ deficit of $14.3M at year-end .
  • Limited liquidity at YE 2024 ($2.9M cash) before the announced SEED share sale; risk disclosures include the ability to meet Nasdaq continued listing requirements .
  • Discontinued operations contributed additional net loss ($7.8M), reflecting SEED’s classification as discontinued operations under ASC 205-20 .

Financial Results

FY Results vs. Prior Year (Q4 not disclosed)

MetricFY 2023FY 2024
Revenue ($USD)$0 $0
R&D Expense ($USD Millions)$7.27 $2.64
G&A Expense ($USD Millions)$7.81 $6.11
Loss from Operations ($USD Millions)$15.08 $8.75
Net Loss – Continuing Ops ($USD Millions)$14.02 $8.87
Net Loss – Discontinued Ops ($USD Millions)$7.93 $7.83
Net Loss Attributable to BeyondSpring ($USD Millions)$21.03 $11.12
EPS – Continuing Ops (Basic/Diluted, $)($0.34) ($0.21)
EPS – Discontinued Ops (Basic/Diluted, $)($0.20) ($0.07)
EPS – Total (Basic/Diluted, $)($0.54) ($0.28)
Cash & Cash Equivalents ($USD Millions)$5.40 $2.92
Total Liabilities ($USD Millions)$48.27 $48.60
Total Shareholders’ Deficit ($USD Millions)($35.34) ($14.29)

Notes:

  • BYSI does not provide quarterly detail; Q4 2024 metrics were not separately disclosed in filings/press releases .

Segment Breakdown

  • Not applicable; no commercial revenue segments reported .

Clinical KPIs

KPIStudyPrior Period (ESMO Sep-24)Current Period (Nov-24/SITC)
Confirmed ORR (%)30321.1% 21.1%
Median PFS (months)3038.63 8.6
Disease Control Rate (%)30389.5% 89.3%
OS HR (ITT) vs. DocetaxelDUBLIN-30.81 (24-month follow-up) 0.81 (published)
Grade 4 Neutropenia ReductionDUBLIN-382% (Cycle 1 Day 8, p<0.0001) 81–85% reductions across cycles

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Study 303 (NSCLC after PD-1/L1) – Updated Data1H 2025Not previously datedUpdated Phase 2 data expected 1H 2025 Introduced
Study 302 (1L ES-SCLC) – Preliminary Data2H 2025Not previously datedPreliminary Phase 2 data expected 2H 2025 Introduced
Plinabulin Regulatory Strategy2025PlanningPreparing NMPA submission; potentially other jurisdictions Maintained/clarified
SEED RBM39 Degrader – INDMid-2025Not previously datedIND expected mid-2025 Introduced
SEED RBM39 Degrader – Patient Enrollment2H 2025Not previously datedPatient enrollment expected 2H 2025 Introduced
SEED Tau Degrader – In vivo efficacy2H 2025Not previously datedIn vivo efficacy expected 2H 2025 Introduced

No financial guidance (revenue/margins/OpEx/tax) was provided .

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript was found in our document set; trends compiled from recent press releases [List: earnings-call-transcript, none for 2024–2025].

TopicPrevious Mentions (Q-2, Q-1)Current Period (Q4 2024)Trend
NSCLC Phase 3 (DUBLIN-3) efficacyESMO/IASLC: OS/PFS/ORR benefits, neutropenia reduction, favorable B/R ratio Lancet publication cited; supports regulatory submission planning Strengthening
NSCLC Phase 2 (Study 303) immune re-sensitizationInterim (n=19): ORR 21.1%, mPFS 8.63m, DCR 89.5% Updated (n=30): ORR 21.1%, mPFS 8.6m, DCR 89.3%; tolerability maintained Consistent/positive
Regulatory strategy (NMPA)Emphasis on dossier for NSCLC “Strengthens regulatory strategy… preparing for submission to NMPA” Advancing
SEED partnerships & financingLilly collaboration milestones; Eisai collaboration announced; Series A-3 first close Eisai collaboration (up to $1.5B), $24M A-3 first close; designations for RBM39 Positive momentum
Liquidity actionsN/A$35.4M sale of portion of SEED A-1 preferred shares to fund Plinabulin trials Improving liquidity

Management Commentary

  • “2024 was a pivotal year… Plinabulin demonstrated a statistically significant survival benefit… strengthens our regulatory strategy as we prepare for submission to the NMPA and potentially regulatory authorities in other jurisdictions.” — Dr. Lan Huang, Co-Founder, Chairman, and CEO .
  • “Plinabulin is a potent inducer of dendritic cell… Compared to historical controls of 3–4 months of median PFS, the efficacy data… doubled median PFS at 8.6 months… encouraging and clinically meaningful.” — Dr. Mengzhao Wang, Principal Investigator (Study 303) .

Q&A Highlights

  • No Q4 2024 earnings call transcript found; no Q&A disclosures available in our document set [List: earnings-call-transcript].

Estimates Context

  • S&P Global consensus estimates for Q4 2024 EPS and revenue were unavailable for BYSI (no data returned). As BYSI does not disclose quarterly financials and reported only full-year 2024, a vs-estimates comparison for Q4 is not applicable. Values retrieved from S&P Global.*

Key Takeaways for Investors

  • DUBLIN-3 publication and consistent Study 303 signals reinforce Plinabulin’s efficacy and potential to re-sensitize tumors after PD-1/L1 resistance; regulatory filing planning with NMPA is a pivotal 2025 catalyst .
  • Liquidity improved post YE-2024 via announced $35.4M sale of a portion of SEED shares, intended to fund late-stage Plinabulin trials; monitor closing tranches and cash runway .
  • SEED Therapeutics adds optionality: Eisai collaboration (up to $1.5B potential payments) and Series A-3 financing underpin RBM39 IND and enrollment milestones in 2025; BYSI retains a meaningful stake .
  • Expense discipline lowered R&D and G&A in 2024, narrowing the continuing-ops net loss; watch 2025 OpEx trajectory as trials and regulatory activities progress .
  • Absence of quarterly disclosures and consensus estimates reduces near-term trading clarity; stock narrative likely tied to clinical/regulatory news flow rather than fundamentals prints .
  • Risk factors include financing needs, regulatory outcomes, and listing compliance; PMs should size positions with binary event risk in mind .
  • Near-term watchlist: Study 303 updated data (1H25), Study 302 preliminary (2H25), RBM39 IND/mid-2025; any NMPA submission updates or partnership activity could be stock-moving .