Candel Therapeutics, Inc. (CADL)·Q4 2024 Earnings Summary

Executive Summary

• Q4 2024 delivered multiple clinical wins (phase 3 prostate DFS benefit; phase 2a PDAC final OS) alongside materially extended cash runway; net loss widened quarter-over-quarter driven by non-cash warrant liability fair value change, while operating expenses declined year-over-year .
• The company completed a $92M gross offering in December, resulting in ~$85.9M net proceeds and year-end cash of $102.7M, extending runway into Q1 2027—reducing near-term financing risk and supporting BLA readiness for CAN-2409 in prostate cancer (submission targeted Q4 2026) .
• No earnings call transcript was available for Q4; management’s press materials emphasize regulatory engagement, upcoming data disclosures (NSCLC/PDAC OS in Q1 2025), and CAN-3110 rHGG updates in Q4 2025 .
• Catalysts: phase 3 prostate data presentations/publication, Q1 2025 NSCLC/PDAC OS updates, BLA preparation milestones, and CAN-3110 biomarker/OS updates in 2025, which may drive investor sentiment and stock action .

What Went Well and What Went Wrong

What Went Well

• Phase 3 prostate trial met the primary endpoint with statistically significant DFS improvement (HR 0.7; p=0.0155); 80.4% pCR in 2-year biopsies vs 63.6% control; favorable safety profile without new signals .
• Phase 2a PDAC final OS showed median 31.4 months vs 12.5 months in control; long-term survivors remained alive at 66.0, 63.6, and 35.8 months; FDA orphan and fast track designations support regulatory pathway .
• Liquidity strengthened via December raise—$92M gross, ~$85.9M net; cash rose to $102.7M at 12/31/24 with runway into Q1 2027, supporting BLA readiness and pipeline progression .

Management quote: “We enter 2025 well-resourced with a clear direction and mandate. Our primary focus for the year is working toward readiness to submit CAN-2409’s BLA for prostate cancer…” .

What Went Wrong

• GAAP net loss widened Q/Q to $14.1M from $10.6M, largely due to non-cash warrant liability fair value change (-$5.8M in Q4 vs -$1.6M in Q3), adding volatility to reported results .
• No statistically significant benefit observed in the active-surveillance phase 2 low/intermediate-risk prostate study (numerical improvements only), limiting near-term optionality in that subpopulation .
• No revenue reported; margins not meaningful for a clinical-stage portfolio, and no Q4 earnings call transcript available to clarify nuances or guide near-term financial expectations .

Financial Results

Summary Financials vs Prior Quarters

Notes: Revenue was not reported in the Q2–Q4 press release financial statements; margins are not meaningful given the absence of revenue reporting .

Balance Sheet Highlights

Clinical KPIs (selected outcomes)

Guidance Changes

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript available; themes inferred from Q2–Q4 press materials.

Management Commentary

• “Last year was transformational for Candel… We delivered positive data across our platforms, including pivotal topline phase 3 data for CAN-2409 in intermediate-to-high-risk localized prostate cancer in December…” — Paul Peter Tak, President & CEO .
• “We enter 2025 well-resourced with a clear direction and mandate. Our primary focus for the year is working toward readiness to submit CAN-2409’s BLA for prostate cancer…” .
• “If approved, we believe that CAN-2409 has the potential to become a first-line treatment… and to redefine the current standard-of-care for prostate cancer patients.” .

Q&A Highlights

No Q4 2024 earnings call transcript was available; therefore, Q&A themes and clarifications were not accessible for this quarter [ListDocuments returned none].

Estimates Context

Wall Street consensus (S&P Global) for Q4 2024 EPS and revenue was unavailable due to request limitations at the time of query; thus, we cannot quantify beats/misses vs estimates for this quarter. Results should be interpreted primarily through reported GAAP metrics and clinical milestones until consensus can be obtained [GetEstimates error].

Key Takeaways for Investors

• The phase 3 prostate DFS win and high pCR in biopsies, coupled with favorable safety, underpin a credible path toward a Q4 2026 BLA submission; regulatory engagement is the next determinant of timeline certainty .
• Liquidity de-risked: December offering and year-end cash of $102.7M extend runway into Q1 2027, supporting BLA readiness and multiple data readouts without near-term financing pressure .
• Reported net loss volatility is largely driven by non-cash warrant liability fair value changes; operating expenses continue to trend down year-over-year—focus on cash utilization and non-cash items when evaluating quarterly results .
• PDAC and NSCLC signals (mOS 31.4 months and 20.6 months, respectively) bolster platform breadth; Q1 2025 updates could validate durability and inform trial design for next-phase studies .
• Absence of revenue limits margin analysis; near-term stock drivers are clinical/regulatory catalysts (data presentations/publication, FDA interactions) rather than near-term P&L .
• Key 2025 milestones: Q1 NSCLC/PDAC OS updates; conference presentations for prostate phase 3; CAN-3110 Q4 biomarker/OS updates—each may reset expectations and influence positioning .
• Trading implications: Expect event-driven volatility around data disclosures and FDA communications; medium-term thesis hinges on successful BLA preparation, regulatory alignment for prostate, and progression of CAN-2409 and CAN-3110 into later-stage development .