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Calidi Biotherapeutics, Inc. (CLDI)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 net loss to common shareholders improved to $4.1 million, or $0.27 per share, with both R&D and G&A materially lower year over year; year-end cash was $9.6 million following multiple financings in Q4 and January, and management terminated the SEPA citing removal of a potential stock overhang .
  • EPS materially beat Wall Street consensus for Q4 (actual -$0.27 vs -$4.44 consensus*) and continued the improvement trend from Q2 and Q3, while revenue remains non-material for this clinical-stage biotech .
  • Clinical and platform milestones were advanced: IND filed for CLD-201 in March 2025, Northwestern began recruitment for CLD-101 Phase 1, and systemic CLD-400 demonstrated payload delivery to tumors; first patient dosing targets were set for Q2–Q3 2025 .
  • Near-term catalysts include CLD-400 payload and lead candidate reveal (Q2 2025), first patient dosing (CLD-101, Q2 2025; CLD-201, Q3 2025), and strengthened liquidity that reduces financing overhang risk per management commentary .

What Went Well and What Went Wrong

What Went Well

  • Material EPS beats and operating expense reductions: Q4 EPS improved to -$0.27 with R&D at $1.8M and G&A at $2.2M, down sharply vs Q4 2023 ($4.0M R&D; $5.9M G&A) .
  • Platform progress across three programs: “CLD-400 proved it can deliver a gene therapy payload to targeted tumors, we filed an IND for CLD-201, and our CLD-101 program … is advancing in two Phase 1 trials” — CEO Allan Camaisa .
  • Liquidity strengthened: year-end cash of $9.6M; SEPA terminated after Q4/Q1 financings, with management stating the move “remove[s] a potential overhang in our stock” .

What Went Wrong

  • No reported product revenue; the company remains pre-revenue and reliant on external financing and grants .
  • Timelines adjusted: CLD-101 Northwestern trial commencement moved from “early 2025” (Q3 release) to “Q2 2025 first patient dosed,” implying a push to later in H1 .
  • Ongoing capital needs and risk disclosures persist; management highlights the need to raise sufficient capital for trials and regulatory risks in forward-looking statements .

Financial Results

EPS vs Wall Street Consensus and Operating Expenses

MetricQ2 2024Q3 2024Q4 2024
EPS (GAAP, $)-$1.40 -$0.65 -$0.27
EPS Consensus Mean (S&P Global, $)-$17.4007*-$10.26041*-$4.44018*
R&D Expense ($USD Millions)$2.167 $2.153 $1.800
G&A Expense ($USD Millions)$3.605 $3.073 $2.200
Cash Balance ($USD Millions)$0.8 $1.9 $9.6

Values retrieved from S&P Global.*

Q4 Year-over-Year Comparison

MetricQ4 2023Q4 2024
Net Loss to Common ($USD Millions)$8.2 $4.1
EPS (GAAP, $)-$0.23 -$0.27
R&D Expense ($USD Millions)$4.0 $1.8
G&A Expense ($USD Millions)$5.9 $2.2
Cash ($USD Millions)$1.9 $9.6

Note: The company did not report product revenue in these periods and remains pre-revenue .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CLD-101 (NeuroNova) first patient dosing2025“Phase 1b/2 … expected to commence in early 2025 at Northwestern University” “Q2 2025: First patient dosed in CLD-101 Phase 1 trial in collaboration with Northwestern University” Timeline pushed to Q2 (later within H1)
CLD-201 (SuperNova) IND and first patient dosing2025Platform positioned to advance into clinic; no specific timing disclosed “IND filed in March 2025; Q3 2025: First patient dosed in CLD-201 Phase 1 trial” New, formalized schedule (clarified/initiated)
CLD-400 (RTNova systemic platform) payload/lead revealQ2 2025Not previously time-bound in Q3/Q2 releases “Q2 2025: Payload and lead candidate information revealed on CLD-400 systemic platform” New milestone disclosure
Financing framework (SEPA)Jan 2025SEPA available up to $25M (never exercised) SEPA terminated; management cites removal of potential stock overhang Eliminated facility; reduces perceived dilution overhang

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript or prepared remarks were located; themes are drawn from company press releases.

TopicPrevious Mentions (Q2 2024 and Q3 2024)Current Period (Q4 2024)Trend
CLD-101 (NeuroNova)FDA cleared Northwestern IND; commence early 2025 Northwestern recruitment began; first patient dosing targeted for Q2 2025 Advancing; timeline refined/pushed to Q2
CLD-201 (SuperNova)New U.S. patent strengthens platform; positioned to advance to clinic IND filed March 2025; first patient dosing targeted Q3 2025 Transitioning to clinical; concrete timing set
CLD-400 (RTNova systemic)Presented data at IOVC/SITC/Immuno US Demonstrated payload delivery to tumors; payload/lead reveal planned Q2 2025 Technical validation; near-term reveal catalyst
Financing/LiquidityRaised $2M (Oct), warrants and ATM proceeds in Q2/Q3 $9.5M Q4 offerings + $2.0M warrants + $3.1M ATM; $4.25M Jan 2025; SEPA terminated Strengthened cash; reduced perceived overhang
R&D ExecutionProgress across programs; advisory board additions Dual Phase 1 paths (CLD-101 physician-led and Northwestern), CLD-201 IND, CLD-400 payload delivery Multi-program momentum

Management Commentary

  • “Calidi continues to make great progress on all three of our platforms; our systemic asset CLD-400 proved it can deliver a gene therapy payload to targeted tumors, we filed an IND for our solid tumor asset CLD-201, and our CLD-101 program treating high-grade glioma is advancing in two Phase 1 trials.” — Allan Camaisa, CEO .
  • “We think our multi-modal mechanism of action is a game changer in treating multiple deadly cancers…” — Allan Camaisa, CEO .
  • “With the successful completion of recent financing activities, we are well-positioned to focus on our clinical and operational goals and remove a potential overhang in our stock.” — Allan Camaisa, CEO .

Q&A Highlights

  • Not applicable; no Q4 2024 earnings call transcript or Q&A was identified.

Estimates Context

  • Consensus EPS for CLDI was -$17.40 in Q2 2024*, -$10.26 in Q3 2024*, and -$4.44 in Q4 2024*; CLDI reported -$1.40, -$0.65, and -$0.27 respectively, representing significant beats as operating spend trended down and share count rose versus prior periods .
  • Consensus revenue was $0.0 in Q2–Q4 2024*, consistent with the company reporting no product revenue in releases .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Liquidity improved meaningfully (year-end cash $9.6M) and SEPA termination reduces perceived dilution overhang; financing activity in Q4 and January provides flexibility for near-term clinical execution .
  • Near-term clinical catalysts: CLD-400 payload/lead reveal (Q2 2025), first patient dosed for CLD-101 (Q2 2025) and CLD-201 (Q3 2025); these events can re-rate program visibility and sentiment .
  • Expense discipline: R&D and G&A continue to trend lower year over year, contributing to outsized EPS beats vs consensus despite pre-revenue status .
  • Program breadth is a differentiator (systemic and localized virotherapy platforms); management’s emphasis on multi-modal MoA targets metastatic and solid tumors, expanding potential addressable indications .
  • Watch for capital markets sensitivity: while cash has been bolstered, ongoing trial activity and regulatory timelines imply continued funding needs; risk disclosures highlight financing and regulatory uncertainties .
  • Trading implication: Upcoming Q2/Q3 2025 milestones and the stated removal of stock overhang could serve as catalysts; position sizing should account for typical biotech volatility around clinical updates .
  • Estimate paths: Given consistent EPS outperformance vs sparse consensus coverage, expect analysts to reassess expense trajectories and cash runway post Q4/Jan financings; revenue remains negligible in the near term.*

Values retrieved from S&P Global.*