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CI

CHIMERIX INC (CMRX)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 results reflected a development-stage profile: minimal revenue ($0.129M) and net loss of $20.7M ($0.23 EPS), with R&D spend rising on ACTION study execution; cash and investments totaled $171.5M and no debt .
  • Management reiterated Phase 3 ACTION first interim OS readout timing for Q3 2025 and highlighted continued enrollment momentum across >140 sites in 13 countries, building U.S. launch readiness ahead of the interim data .
  • ONC206 Phase 1 intensified dosing achieved sustained biologically active plasma concentrations beyond 24 hours with no dose-limiting toxicities to date; dose escalation expected to complete in 2024, with initial objective response assessment targeted for 1H25 .
  • Australia pathway advanced: dordaviprone Provisional Determination filed; management sees potential to apply for Provisional Registration by year-end 2024 with possible commercial availability in 2026, offering an early ex-U.S. catalyst .
  • Wall Street consensus (S&P Global) was unavailable for CMRX at the time of this analysis due to mapping limitations; estimate-based beat/miss analysis cannot be provided (see Estimates Context).

What Went Well and What Went Wrong

What Went Well

  • ACTION on track: “Our team continues to be laser focused on the execution and enrollment of the Phase III ACTION study, which is on track for the first interim overall survival readout in the third quarter of next year.”
  • ONC206 safety/PK: “Biologically active concentrations of ONC206 were sustained for beyond 24 hours in plasma… peak plasma concentrations are well in excess of the compound’s IC50… with no meaningful changes in the overall adverse event profile as dosing has either escalated up or become more frequent.”
  • Balance sheet strength and runway: CFO noted average burn of ~$16M per quarter over the past six months and runway “into 4Q of 2026” under current plan, providing funding capacity through key data milestones .

What Went Wrong

  • Ongoing losses and limited revenue: Net loss widened YoY to $20.7M with negligible revenue ($0.129M), reflecting continued R&D investment and lack of commercial products .
  • Higher R&D: Q2 R&D rose to $18.4M vs $16.9M YoY, driven primarily by ACTION study spend, pressuring near-term P&L .
  • No near-term efficacy readout for ONC206: Initial objective response assessment is not expected until 1H25; interim ACTION OS remains 2025, limiting immediate clinical catalysts .

Financial Results

Quarterly Comparison (Q4 2023 → Q1 2024 → Q2 2024)

MetricQ4 2023Q1 2024Q2 2024
Revenue ($USD Thousands)$4,814 $0 $129
Net Loss ($USD Millions)$(18.161) $(21.869) $(20.685)
Diluted EPS ($USD)$(0.20) $(0.25) $(0.23)
R&D Expense ($USD Millions)$15.642 $18.844 $18.428
G&A Expense ($USD Millions)$5.172 $5.546 $4.533
Interest & Other Income ($USD Millions)$2.649 $2.521 $2.147

YoY Comparison (Q2 2024 vs Q2 2023)

MetricQ2 2023Q2 2024Change
Revenue ($USD Thousands)$26 $129 +$103
Net Loss ($USD Millions)$(18.576) $(20.685) $(2.109)
Diluted EPS ($USD)$(0.21) $(0.23) $(0.02)
R&D Expense ($USD Millions)$16.926 $18.428 +$1.502
G&A Expense ($USD Millions)$4.448 $4.533 +$0.085

Balance Sheet and Liquidity

MetricQ1 2024 (Mar 31)Q2 2024 (Jun 30)
Cash & Cash Equivalents ($USD Millions)$19.026 $15.658
Short-term Investments ($USD Millions)$140.002 $132.511
Long-term Investments ($USD Millions)$29.133 $23.315
Capital Available to Fund Operations ($USD Millions)$188.2 $171.5
Shares Outstanding (Millions)~89.7 ~89.6
DebtNone None

Segment breakdown: Not applicable; company has no commercial segment revenue .

KPIs

KPIQ4 2023Q1 2024Q2 2024
ACTION sites activated (countries)113 (12) >135 (13) >140 (13)
Interim OS timing (ACTION)Early 20252025 Q3 2025
ONC206 dose schedule statusWeekly completed; intensifying frequency Intensified dosing ongoing Sustained biologically active concentrations; no DLTs to date
Cash runway (company guidance)>through 2026 final ACTION data N/AInto 4Q 2026

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ACTION interim OS readout2025“Early 2025”Q3 2025 Refined timing (later in year)
ACTION enrollment footprintOngoing113 sites / 12 countries (Nov-2023) >140 sites / 13 countries (Aug-2024) Expanded sites/countries
ONC206 dose escalation completion2024“Completion beginning in mid-2024” “Complete enrollment by end of 2024” Maintained; clarified end-year
ONC206 safety/PK disclosures2024/2025Preliminary safety/PK mid-2024 Additional safety/PK after YE; objective response assessment 1H25 Timeline specified
Australia (dordaviprone) regulatory path2024–2026Pre-Submission meeting completed; eligible to file Provisional Determination Provisional Determination filed; potential Provisional Registration application by YE 2024; possible commercial availability in 2026 Advanced to next step
Launch readiness spend2H24–2025N/AModest OpEx increase in 2H24; gated spend through 2025 New guidance
Cash runwayThrough 2026End-2023: >$200M cash to fund to 2026 Runway into 4Q 2026 Maintained; clarified quarter

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2023, Q1 2024)Current Period (Q2 2024)Trend
ACTION Enrollment/TimingEarly 2025 interim OS; 113 sites/12 countries (Q4’23). 2025/2026 OS; >135 sites/13 countries (Q1’24) Q3 2025 interim OS; >140 sites/13 countries; balanced U.S./EU/Asia enrollment Stable execution; footprint expanding
Australia Regulatory PathEligibility to file Provisional Determination (Q1’24) Provisional Determination filed; Provisional Registration filing potential YE’24; ex-U.S. lean model under study Advancing
ONC206 DevelopmentDose intensification planned; no DLTs (Q4’23, Q1’24) Sustained active concentrations >24h; no DLTs; enrollment to complete by YE’24; response assessment 1H25 Progressing to potential efficacy signals
Launch ReadinessN/A; building capabilities (Q1’24 mgmt changes) Gated spend; modest 2H24 OpEx increase; payer/investigator engagement Building
Cash Runway>200M cash to fund through 2026 (Q4’23) Runway into 4Q 2026; ~$16M/quarter burn recent average Stable/clearer
Geographic EnrollmentGlobal interest (Q4’23) Proportional contributions U.S./Europe/Asia Stable diversification

Management Commentary

  • CEO: “We continued our strong execution of the Phase 3 ACTION study and expect the first interim overall survival (OS) data in the third quarter of 2025. As we approach this important milestone, we continue to strengthen our U.S. launch capabilities and readiness.”
  • CEO: “We have also made progress expanding the global reach for dordaviprone with the recent filing of a Provisional Determination application in Australia.”
  • CSO (ONC206): “At 100 milligrams twice a day for 3 days per week, the human PK results show that biologically active concentrations of ONC206 were sustained for beyond 24 hours in plasma… and that peak plasma concentrations are well in excess of the compound’s IC50 in vitro.”
  • CFO: “This discipline has allowed us to maintain an average burn for the past 6 months of about $16 million a quarter… we expect to have cash into 4Q of 2026.”

Q&A Highlights

  • ONC206 cohorts and response timing: Management expects final dose cohorts to follow a 3+3 paradigm; safety readouts follow ~1-month DLT windows; initial objective response readout targeted 1H25 to allow confirmation and durability assessment .
  • Tumor types for ONC206: Moving beyond glioblastoma/H3 K27M to include medulloblastoma and other CNS tumors with mechanistic rationale; first medulloblastoma patient enrolled .
  • ACTION trial metrics: Enrollment is balanced across U.S., Europe, and Asia; blinded event rates “just now beginning to come in,” with more updates coming .
  • Australia commercialization approach: Pursuing lean model and potential distribution partnerships to minimize expense; regulatory steps precede detailed commercial structure .
  • Launch investments: Gated spend aligned to milestones; modest increase in 2H24; payer and stakeholder engagement underway .

Estimates Context

  • Wall Street consensus via S&P Global was unavailable for CMRX due to a mapping limitation (CIQ company ID not found). As a result, comparisons to consensus estimates and beat/miss analysis cannot be provided at this time. Future updates will anchor to S&P Global consensus when available.

Key Takeaways for Investors

  • ACTION remains the primary value driver; interim OS readout now pinpointed to Q3 2025, with global enrollment momentum and expanding site footprint supporting timely event accrual .
  • ONC206 program is de-risking on safety/PK with intensified dosing achieving sustained active exposures and no DLTs; 2024 completion of dose escalation sets up a 1H25 efficacy signal opportunity across select CNS indications .
  • Australian pathway offers an earlier regulatory and commercial option (Provisional Registration) potentially by YE’24 filing, enabling 2026 market availability, while preserving a lean ex-U.S. model .
  • Liquidity is solid with $171.5M capital available and no debt; CFO cites ~$16M quarterly burn and runway into 4Q 2026, supporting execution through interim data and early launch readiness .
  • Near-term stock catalysts likely center on regulatory milestones (Australia Provisional Registration submission), ACTION enrollment/status updates, and ONC206 safety/PK disclosures as dose escalation completes .
  • Estimate benchmarking was not possible this quarter due to S&P mapping constraints; as consensus becomes available, focus on spend trajectory, cash runway, and timing sensitivity of ACTION milestones for valuation impact.
  • Key risk remains clinical performance (ACTION OS and ONC206 efficacy); program breadth across CNS tumors and mechanistic validation mitigates some risk, but timelines push meaningful efficacy catalysts into 2025 .