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Calidi Biotherapeutics, Inc. (CLDI)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was operationally active with CEO and CMO appointments, IL‑15 superagonist identified as the first Redtail payload, and FDA IND clearance for CLD‑201; GAAP net loss narrowed year over year as OpEx declined .
  • GAAP EPS was −$0.18 vs −$2.03 a year ago on lower G&A and R&D; cash increased to $10.6M from $9.6M in Q4 2024, reflecting recent financings .
  • No product revenue; Wall Street consensus expected zero revenue and Primary EPS of −$1.80 for Q1; S&P recorded Primary EPS actual of −$2.25*, which differs from company GAAP (definition differences, share count effects). This constitutes a miss vs S&P’s consensus on its Primary EPS metric* .
  • Near‑term stock catalysts: Redtail preclinical payload data (AACR presentation), CLD‑201 Phase 1 initiation, and CLD‑101 dosing at Northwestern; financing overhang reduced via SEPA termination .

What Went Well and What Went Wrong

What Went Well

  • CEO transition to Eric Poma (ex‑MTEM CEO) and appointment of CMO Guy Travis Clifton, adding deep biopharma and clinical trial leadership. “We are extremely excited about the progress at Calidi” .
  • Redtail systemic platform advanced with IL‑15 superagonist as first payload and new preclinical data presented at AACR, supporting immune‑evasive, tumor‑targeted virotherapy with non‑integrating genetic payload delivery .
  • Cash rose to $10.6M at quarter end and SEPA was terminated, removing a potential financing overhang; January 2025 offering added $4.25M gross .

What Went Wrong

  • No revenue; operating model continues to rely on external financing amid clinical development (pre‑commercial) .
  • Ongoing net losses: Q1 GAAP net loss of $5.0M; OpEx remained ~$5.1M as clinical and platform investments continue .
  • S&P Global’s Primary EPS actual metric indicated a larger loss than consensus (−$2.25 vs −$1.80, one estimate), highlighting definition/denominator mismatches vs company GAAP and limited sell‑side coverage.

Financial Results

Quarterly GAAP KPIs

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)N/AN/AN/A
Net Loss ($USD Millions)$5.07 $4.10 $5.06
GAAP EPS (Basic & Diluted) ($)−$0.65 −$0.27 −$0.18
R&D Expense ($USD Millions)$2.15 $1.88 $2.43
G&A Expense ($USD Millions)$3.07 $2.20 $2.64
Total Operating Expense ($USD Millions)$5.23 N/A$5.06
Cash & Restricted Cash ($USD Millions, period end)$2.10 $9.80 $10.80

Notes: Company statements present quarterly OpEx totals for Q3 and Q1; Q4 totals are provided as component lines (R&D, G&A) but not explicitly totaled in the press release.

Q1 2025 vs Wall Street Consensus (S&P Global)

MetricActual Q1 2025Consensus Q1 2025# of Estimates
Primary EPS ($)−2.25*−1.80*1*
Revenue ($USD Millions)N/A0.00*1*

Values marked with * retrieved from S&P Global. Company‑reported GAAP EPS for Q1 2025 was −$0.18 .

Segment Breakdown

  • Not applicable; Calidi is a clinical‑stage biotech without reported commercial segments .

Additional Operating Metrics

  • Weighted average shares (basic/diluted): 27.086M (Q1 2025), 7.824M (Q3 2024) .
  • Balance sheet shift: Total equity improved to $7.3M at 3/31/25 vs $2.0M at 12/31/24, reflecting financing and liability changes .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Redtail (CLD‑400) payload disclosureQ2 2025“Payload and lead candidate information revealed on CLD‑400 systemic platform” IL‑15 superagonist selected; new preclinical data presented at AACR Apr 27, 2025 Achieved/advanced
CLD‑201 IND statusH1 2025IND filing in March 2025 FDA IND cleared; moving to clinical development in solid tumors Raised (milestone achieved)
CLD‑101 Northwestern trialQ2 2025First patient dosing anticipated in Q2 2025 Recruitment underway; first‑patient dosing milestone remains upcoming Maintained
Financing framework2025SEPA available up to $25M (unutilized) SEPA terminated; cash bolstered via offerings and ATM Policy change (overhang reduced)

No formal financial guidance (revenue/margins/tax rate) was issued .

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was found/published for CLDI during the period [List: 0 transcripts].

TopicPrevious Mentions (Q3 2024 and Q4 2024)Current Period (Q1 2025)Trend
Redtail systemic platformRTNova (CLD‑400) data presented at IOVC/SITC; systemic immune‑evasive design IL‑15 superagonist selected; AACR data presented supporting payload delivery and antitumor immunity Advancing
CLD‑201 programIND filing targeted; filed in March 2025 FDA IND cleared; moving to clinical development in adults (breast, H&N, sarcoma) Positive inflection
CLD‑101 (NeuroNova)FDA IND clearance for Northwestern; recruitment planned; City of Hope trial at 14 patients Northwestern recruitment ongoing; first patient dosing expected Q2 2025 Continuing
Financing and cash runwayQ3: $2M raised Oct 2024; Q4: offerings and ATM raised ~$14.6M gross SEPA terminated; cash at $10.6M end‑Q1 Strengthened
Management changesCEO transition to Eric Poma; CMO appointment of Dr. Clifton Strategic upgrade
Regulatory/legalIND filings and clearances; NCI‑sponsored trial Additional IND clearance (CLD‑201) Improving

Management Commentary

  • “We are extremely excited about the progress at Calidi… We believe our systemic antitumor virotherapy platform, Redtail… will be a substantial breakthrough in the field of oncolytic viruses and tumor‑targeted gene therapies.” — Eric Poma, PhD, CEO .
  • “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… is advancing in two Phase 1 trials.” — Allan Camaisa, CEO (Q4 release) .

Q&A Highlights

  • No formal Q1 2025 earnings call transcript was available; therefore, no Q&A themes to report for the period [List: 0 transcripts].

Estimates Context

  • S&P Global consensus for Q1 2025 Primary EPS was −$1.80 (1 estimate); S&P’s recorded Primary EPS actual was −$2.25, a miss of $0.45 and roughly 24.8% below consensus*. Company‑reported GAAP EPS was −$0.18 .
  • Revenue consensus was $0.00 (1 estimate)*, consistent with the company’s pre‑commercial status.

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Platform momentum: Redtail’s payload selection and AACR data raise visibility of systemic oncolytic virotherapy; CLD‑201 IND clearance is a key de‑risking step .
  • Clinical catalysts: Watch for CLD‑101 first patient dosing (Northwestern) and CLD‑201 Phase 1 initiation; data updates from City of Hope’s recurrent HGG trial could be stock‑moving .
  • Financing stance: SEPA termination removes dilution overhang; cash improved to $10.6M, but continued trial execution implies ongoing capital needs and timing sensitivity .
  • Earnings print: GAAP EPS improved year over year (−$0.18 vs −$2.03), driven by lower G&A and R&D; however, S&P’s Primary EPS framework indicates a miss versus its consensus*, underscoring low‑coverage/metric disparities .
  • Risk factors: Pre‑revenue biotech with regulatory, clinical, and funding risks; management upgrades aim to strengthen execution, partnerships, and capital markets access .
  • Trading setup: Near‑term catalysts are predominantly clinical/regulatory; press‑release‑driven momentum likely, but durability depends on trial starts and any interim safety/efficacy signals .
  • Medium‑term thesis: If Redtail’s systemic delivery and transient payload approach continues to show translational progress, optionality spans lung, ovarian, and broader metastatic settings; partner interest could accelerate timelines .