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Cadrenal Therapeutics, Inc. (CVKD)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was pre-revenue with net loss of $3.85M and diluted EPS of $(2.09); operating expenses rose sharply YoY (Opex $3.93M vs $1.76M), driven by higher R&D and G&A as the company advanced tecarfarin development .
  • EPS modestly beat Wall Street consensus by $0.06 (Actual $(2.09) vs $(2.15) est; 1 estimate), while revenue was in line at $0 given pre-commercial status (2 revenue estimates) — limited coverage indicates low estimate conviction* .
  • Strategic catalysts: FDA Type D meeting provided pivotal trial design guidance; collaboration agreement with Abbott to support TECH-LVAD trial; technical transfer of API manufacturing to U.S. CDMO to fortify supply chain .
  • Sequentially, cash declined to $7.34M from $10.02M at year-end, reflecting operating burn and investment in trial readiness; shares outstanding were ~1.91M as of March 31, 2025 .
  • Near-term stock narrative hinges on execution milestones (final Phase 3 design, trial initiation, site activation) and external validation (Abbott collaboration), offset by funding needs and elevated OpEx cadence .

What Went Well and What Went Wrong

What Went Well

  • FDA engagement: “The FDA provided additional guidance on the appropriate design for a Phase 3 tecarfarin trial and welcomed submission of a final study design for review” .
  • Strategic validation: “The finalized Collaboration Agreement with Abbott validates the critical need in the market for a new anticoagulant for patients with left ventricular assist devices (LVADs)” .
  • Operational de-risking: Completed technical transfer and U.S. manufacturing of tecarfarin API to improve supply chain security .

What Went Wrong

  • Cost escalation: R&D rose to $1.7M (vs $0.6M YoY) and G&A to $2.3M (vs $1.1M YoY), expanding OpEx to $3.93M and widening net loss to $(3.85)M (vs $(1.66)M YoY) .
  • Cash drawdown: Cash and equivalents fell to $7.34M from $10.02M at December 31, 2024, reflecting operating burn ahead of Phase 3 .
  • Limited sell-side participation: Only one EPS estimate and two revenue estimates, constraining visibility and consensus quality*.

Financial Results

Income Statement and EPS vs Prior Periods and Estimates

MetricQ1 2024Q4 2024Q1 2025Q1 2025 Consensus
Revenues ($USD Millions)$0.00 $0.00†*$0.00 $0.00*
Total Operating Expenses ($USD Millions)$1.76 $4.28*$3.93 N/A
Net Income - (IS) ($USD Millions)$(1.66) $(4.19)*$(3.85) N/A
Diluted EPS - Continuing Operations ($USD)$(1.56) $(2.55)*$(2.09) $(2.15)*

Notes:

  • Oldest → newest columns.
  • † As a pre-commercial company, CVKD reported no product revenue; Q4 figure shown to maintain consistency.
    • Values retrieved from S&P Global.

Operating Expense Breakdown and Cash

MetricQ1 2024Q4 2024Q1 2025
R&D ($USD Millions)$0.63 N/A$1.67
G&A ($USD Millions)$1.13 N/A$2.25
Other Income ($USD Millions)$0.09 N/A$0.08
Cash and Equivalents ($USD Millions)N/A$10.02 $7.34
Shares Outstanding (Millions)~1.07 ~1.78 ~1.91

KPIs (Operational/Corporate)

KPIQ3 2024Q4 2024Q1 2025
QTD Operating Expenses ($USD Millions)$2.50 $4.28*$3.93
Cash Used in Operations ($USD Millions)$2.20 N/AN/A
FDA InteractionPhase 3 protocol discussions (Sep 2024) Type D meeting (Feb 2025) Type D guidance confirming Phase 3 design path
Strategic PartneringAbbott discussions (Q3) Collaboration Agreement announced (Mar 2025) Collaboration Agreement referenced; scope includes trial design/site identification
  • Values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY/Q1 2025Not provided Not provided Maintained (no formal guidance)
EPSFY/Q1 2025Not provided Not provided Maintained (no formal guidance)
Operating ExpensesFY/Q1 2025Not provided Not provided Maintained (no formal guidance)
Trial Milestones2025Ongoing FDA and Abbott discussions Type D guidance; Collaboration Agreement; U.S. API transfer Advanced qualitatively

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was available; we searched for earnings-call-transcript in the April–June 2025 window and found none [ListDocuments result].

TopicPrevious Mentions (Q-2: Q3 2024)Previous Mentions (Q-1: Q4 2024)Current Period (Q1 2025)Trend
Regulatory/FDADiscussed Phase 3 protocol with FDA (Sep 2024) Type D meeting planned/completed; FDA requested detailed design Type D meeting provided Phase 3 design guidance; submit final design Progressing
Strategic PartnershipsAdvanced Abbott LVAD collaboration discussions Collaboration Agreement announced with Abbott (HeartMate 3) Collaboration Agreement finalized; support on trial design/site identification/awareness Strengthening
Manufacturing/Supply ChainCDMO operational readiness for cGMP supply Trial material readiness reiterated U.S. API technical transfer completed to improve supply chain security De-risking
Financing/LiquidityRaised $9.8M via ATM and warrants; cash ~$11.3M Year-end cash $10.0M Cash $7.34M at 3/31/25 Burn impacting runway
Clinical StrategyEmphasis on LVAD superiority vs warfarin; broader indications Pipeline-in-a-product; ODD/Fast Track reaffirmed Market research supports LVAD expansion; multiple indications assessed Expanding scope

Management Commentary

  • “In the first quarter of 2025, Cadrenal continued to build on the momentum we achieved during 2024” — Quang X. Pham, Chairman & CEO .
  • “The finalized Collaboration Agreement with Abbott validates the critical need in the market for a new anticoagulant for patients with LVADs” .
  • “The FDA provided additional guidance on the appropriate design for a Phase 3 tecarfarin trial and welcomed submission of a final study design” .
  • Operational focus: U.S. API technical transfer to align with clinical/regulatory strategy and improve supply chain security .
  • Strategic positioning: Research indicates LVAD market projected to nearly double by 2032 and supports broader tecarfarin potential across cardiovascular, renal, and mechanical valve indications .

Q&A Highlights

  • No earnings call transcript was available for Q1 2025; therefore, Q&A highlights and tone assessment are not applicable for this quarter [ListDocuments result].

Estimates Context

Results vs Wall Street consensus (S&P Global):

  • EPS: Actual $(2.09) vs $(2.15) est — modest beat; 1 EPS estimate*.
  • Revenue: $0.00 vs $0.00 est — in line; 2 revenue estimates*.
MetricQ1 2025 ConsensusQ1 2025 Actual
Primary EPS Consensus Mean ($)$(2.15)*$(2.09)
Revenue Consensus Mean ($USD Millions)$0.00*$0.00
Primary EPS - # of Estimates1*—
Revenue - # of Estimates2*—
  • Values retrieved from S&P Global.

Key Takeaways for Investors

  • Execution path is clearer: FDA Type D feedback plus Abbott collaboration de-risk trial design and site activation — key catalysts are final design submission and TECH-LVAD initiation .
  • Cost inflection supports development but pressures runway: OpEx ramp to $3.93M and cash decline to $7.34M point to funding visibility as a near-term focus .
  • Pre-revenue status persists; quarterly results hinge on OpEx management and milestone progression rather than top-line metrics .
  • EPS beat was driven by lower-than-expected loss and modest other income ($0.083M), but limited estimate coverage reduces read-through for consensus revisions .
  • Manufacturing transfer to U.S. CDMO is strategically important for regulatory compliance and supply chain resilience heading into Phase 3 .
  • Broader TAM narrative (LVAD growth and additional indications) can support medium-term thesis if clinical execution stays on track .
  • Monitor upcoming disclosures for detailed Phase 3 protocol, trial timelines, and financing plans to sustain operations through pivotal activities .

Sources

  • Q1 2025 8-K with Exhibit 99.1 press release and financial statements .
  • FY 2024 8-K press release and year-end balance sheet .
  • Q3 2024 corporate update press release .
  • Wall Street consensus estimates from S&P Global (EPS, revenue, estimate counts).*