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Corbus Pharmaceuticals Holdings, Inc. (CRBP)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 delivered steady pipeline execution with CRB-701 Western Phase 1 dose-escalation data presented at ASCO GU 2025, FDA Fast Track granted in December for metastatic cervical cancer, and CRB-601 first-patient dosed in December, while CRB-913 remained on track to begin Phase 1 SAD/MAD dosing in March 2025 .
  • GAAP net loss improved sequentially to $9.53M (EPS -$0.78) versus Q3’s $13.78M (EPS -$1.15); Q4 operating expenses fell to $12.61M from $15.51M in Q3 but remained up year over year due to product development and stock-based compensation .
  • Liquidity remains strong with $149.1M in cash, cash equivalents and investments at 12/31/24, supporting a cash runway through Q3 2027 based on current plans .
  • Estimate comparison: S&P Global consensus was unavailable at time of retrieval; beats/misses vs Street could not be assessed (S&P Global estimates unavailable).

What Went Well and What Went Wrong

  • What Went Well
    • Western CRB-701 Phase 1 data: management reported promising safety (no DLTs), low neuropathy/skin toxicity, and clinical responses in multiple tumor types; HNSCC saw multiple responses for the first time in the Western study .
    • Regulatory momentum: FDA Fast Track designation for CRB-701 in relapsed/refractory metastatic cervical cancer enhances regulatory interaction and potential acceleration .
    • Funding runway: $149.1M cash/investments at year-end 2024 with runway through Q3 2027; management emphasized progress across programs and anticipated additional datasets in 2H 2025 .
  • What Went Wrong
    • Continued losses: Q4 GAAP net loss of $9.53M and FY 2024 net loss of $40.21M highlight ongoing investment ahead of revenue generation .
    • Year-over-year OpEx increase: Q4 operating expenses rose to $12.61M from $10.10M in Q4 2023, primarily on product development and stock-based compensation .
    • No revenue reported in quarterly press releases/financial tables; company remains pre-revenue with P&L dominated by R&D and G&A .

Financial Results

  • Quarterly trend (oldest → newest)
MetricQ2 2024Q3 2024Q4 2024
Net Loss ($USD Millions)$9.997 $13.783 $9.530
EPS (Basic & Diluted)-$0.90 -$1.15 -$0.78
Total Operating Expenses ($USD Millions)$10.988 $15.505 $12.605
R&D Expense ($USD Millions)$6.865 $10.808 $8.787
G&A Expense ($USD Millions)$4.123 $4.697 $3.818
Cash, Cash Equivalents & Investments (Quarter-End)$147.0M (6/30/24) $159.4M (9/30/24) $149.1M (12/31/24)
  • Q4 year-over-year comparison
MetricQ4 2023Q4 2024
Net Loss ($USD Millions)$8.022 $9.530
EPS (Basic & Diluted)-$1.81 -$0.78
Total Operating Expenses ($USD Millions)$10.104 $12.605
R&D Expense ($USD Millions)$6.980 $8.787
G&A Expense ($USD Millions)$3.124 $3.818

Notes: Company financial statements and press materials did not include a revenue line, indicating no reported product revenue in these periods .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CRB-701 Western dose-escalation data (first dataset)Q1 2025“Report first data in Q1 2025” “Western study dose-escalation data presented at ASCO GU 2025” (Q1 2025) Achieved/on time
CRB-701 RP2D under Project Optimus4Q 2025Not previously specified“Expect to complete dose optimization and establish RP2D in 4Q 2025” New
CRB-913 Phase 1 SAD/MAD first dosingMarch 2025“Phase 1 to commence in Q1 2025” “Expect to dose first participant in March 2025” Narrowed timing within Q1
CRB-601 First patient dosed4Q 2024“Expect to dose first patient in Q4 2024” “First patient dosed in December 2024” Achieved
CRB-601 Dose escalation completion4Q 2025Not previously specified“Expect to complete dose escalation in 4Q 2025” New
Cash runwayThrough Q3 2027“Runway through Q3 2027” affirmed (6/30/24) “Runway through Q3 2027” reaffirmed (12/31/24) Maintained

Earnings Call Themes & Trends

Note: A Q4 2024 earnings call transcript was not available in the document set; themes below reflect company communications (press releases) across quarters.

TopicPrevious Mentions (Q2 2024, Q3 2024)Current Period (Q4 2024)Trend
CRB-701 efficacy/safetyASCO 2024: 44% ORR and 78% DCR in mUC; 43% ORR and 86% DCR in cervical; low neuropathy/skin toxicity; no DLTs Western study dose-escalation data presented at ASCO GU 2025; safety comparable to China Ph1; low neuropathy/skin toxicity; multiple responses incl. HNSCC Positive continuity; expanding tumor signals
Regulatory (CRB-701)FDA Fast Track for metastatic cervical cancer (Dec 2024) Positive inflection
CRB-913 obesity programPhase 1 expected Q1 2025; preclinical data at Obesity Week 2024 SAD/MAD first dosing expected March 2025; peripherally restricted profile emphasized On schedule
CRB-601 αvβ8 mAbIND cleared; Phase 1 start targeted for Q4 2024 First patient dosed Dec 2024; dose escalation expected complete in 4Q 2025 Execution progress
Funding/runwayCash/investments $147M at 6/30/24; runway through Q3 2027 $149.1M at 12/31/24; runway through Q3 2027 reaffirmed Stable liquidity

Management Commentary

  • CEO tone on progress and near-term catalysts: “During the fourth quarter and into 2025, we made significant progress across our pipeline… We were encouraged by the data for CRB-701 from our study in Western patients… We look forward to generating informative clinical data from all three of our programs in the 2nd half of this year” — Yuval Cohen, Ph.D., CEO .
  • Q3 setup for 2025 readouts: “We expect to report the first data from the CRB-701 U.S. bridging study in Q1 2025… The emerging efficacy and safety data presented at ASCO 2024 was promising… We presented updated pre-clinical data at Obesity Week 2024 and expect to dose the first study participant in Q1 2025” .

Q&A Highlights

  • No Q4 2024 earnings call transcript was located; the company communicated results via press release and 8-K exhibit . No Q&A highlights available.

Estimates Context

  • S&P Global consensus estimates for Q4 2024 were unavailable at the time of retrieval (API rate limit), so we cannot provide a vs. Street comparison for revenue/EPS/EBITDA. Values retrieved from S&P Global.
  • Given limited small-cap biotech coverage and the company’s pre-revenue status in the reported materials, Street estimate visibility may be limited; we recommend revisiting when S&P Global access is available to quantify any beat/miss (S&P Global estimates unavailable).

Key Takeaways for Investors

  • CRB-701 de-risking: Western Phase 1 dose-escalation data presented at ASCO GU 2025 confirmed a favorable safety profile and activity across tumor types, including HNSCC, complementing earlier China data .
  • Regulatory momentum: FDA Fast Track for CRB-701 in metastatic cervical cancer should enhance interactions and could expedite development .
  • Multiple clinical catalysts in 2025: CRB-913 SAD/MAD first dosing in March; CRB-701 dose optimization underway with RP2D targeted in Q4; CRB-601 dose escalation ongoing through 4Q 2025 .
  • Liquidity provides runway: $149.1M in cash/investments at year-end supports operations through Q3 2027, limiting near-term financing overhang under current plans .
  • P&L discipline to watch: Sequential OpEx decline from Q3 to Q4 (15.5 → 12.6) after earlier trial/IND ramp; still up YoY due to development/SBC—monitor spending cadence versus milestone delivery .
  • Pre-revenue profile continues: No revenue reported; investment case remains driven by clinical/regulatory milestones rather than near-term sales/earnings .

Appendix: Other Relevant Q4 2024 Press Releases

  • CRB-701 Fast Track designation (Dec 3, 2024) .
  • CRB-601 first patient dosed (Dec 9, 2024) .
  • CRB-701 Phase 1 dose-escalation enrollment completion (Oct 16, 2024) .

Sources:

  • Q4/FY 2024 press release and 8-K exhibit .
  • Q3 2024 press release .
  • Q2 2024 8-K and press release .