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Cadrenal Therapeutics, Inc. (CVKD)·Q4 2024 Earnings Summary

Executive Summary

  • Cadrenal ended Q4 2024 as a pre-revenue, development-stage company focused on Phase 3 readiness for tecarfarin; FY 2024 net loss was $10.7M and cash was $10.0M at year-end .
  • Operational progress and funding were notable: Q3 OpEx $2.5M, cash used in operations $2.2M, and cumulative financing of ~$9.8M in Q4 via ATM ($5.1M) and warrant exercises ($4.7M) to support pivotal trial plans .
  • Strategic catalysts built into and after Q4: FDA interactions on Phase 3 protocol (Q3 discussions; Type D meeting Feb 3, 2025) and an Abbott collaboration supporting the TECH-LVAD trial (announced Mar 4, 2025) .
  • No Q4 earnings call transcript was found; results were communicated via press releases and the FY 2024 8-K/Exhibit 99.1, limiting direct estimate comparisons and Q&A insights .

What Went Well and What Went Wrong

What Went Well

  • Strengthened liquidity and runway with ~$9.8M raised in Q4 (ATM $5.1M, warrants $4.7M), increasing flexibility for Phase 3 activities .
  • Manufacturing and operational readiness achieved with CDMO to supply clinical materials per cGMP; cash balance cited at ~$11.3M as of Nov 7, 2024 .
  • Engagement with regulators and ecosystem: FDA protocol discussions in Q3; AC Forum Corporate Council membership; industry recognition as “Anticoagulation Therapy Company of the Year” in November .
  • “Momentum is building from our achievement of several critical milestones…” — Quang X. Pham, CEO (Nov 7 press release) .
  • “We have made significant progress with advancing our planned pivotal trial…” — Quang Pham (Aug 7 press release) .
  • “2024… laying the foundations for advancing tecarfarin into Phase 3 clinical development.” — Quang X. Pham (Mar 13, 2025 Exhibit 99.1) .

What Went Wrong

  • FY 2024 net loss expanded to $10.7M versus $8.4M in FY 2023; G&A rose to $6.8M from $3.5M, reflecting higher corporate scale-up costs .
  • Working capital pressure evident: accounts payable increased to $1.50M at year-end 2024 vs. $0.17M in 2023 .
  • No Q4 earnings call transcript available; limited quantitative quarterly detail (e.g., no Q4 EPS or revenue disclosures), constraining vs. estimates analysis .

Financial Results

Annual Results (FY 2023 → FY 2024)

MetricFY 2023FY 2024
General & Administrative ($USD)$3.55M $6.75M
Research & Development ($USD)$4.08M $4.21M
Total Operating Expenses ($USD)$7.63M $10.96M
Net Loss ($USD)$(8.36)M $(10.65)M
Net Loss per Share (basic/diluted)$(9.29) $(8.73)
Cash & Cash Equivalents (period-end)$8.40M $10.02M
Shares Outstanding (period-end)868,184 1,782,486

Notes: All share/per share info retroactively adjusted for 1-for-15 reverse split on Aug 20, 2024 .

Quarterly Operating Metrics Context (Q2 → Q3 → Q4 2024)

MetricQ2 2024Q3 2024Q4 2024
Operating Expenses ($USD)$2.3M (excl. non-cash) $2.5M (incl. $0.3M non-cash) Not disclosed
Cash Used in Operating Activities ($USD)$1.5M $2.2M Not disclosed
Cash Balance (as-of date) ($USD)$5.0M (6/30/2024) $11.3M (11/7/2024) $10.02M (12/31/2024)
Financing ActivityATM $5.1M (10/24); Warrants $4.7M (11/1) Cumulative ~$9.8M raised during year

Notes: Q3 cash balance is as of press release date (Nov 7, 2024), not quarter-end .

Revenue, EPS, Margins vs. Estimates

  • CVKD did not disclose Q4 2024 revenue or EPS; the FY 2024 press release included annual net loss and per-share loss but no quarterly EPS or revenue. Therefore, quarterly vs. estimates comparisons are not available .
  • S&P Global consensus estimates for Q4 2024 could not be retrieved due to access limits at the time of analysis; therefore, comparisons to consensus are unavailable (values would be from S&P Global if accessible).

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Phase 3 LVAD trial (TECH-LVAD)2024–2025Q2: Initiated collaborative effort with Abbott; developing LVAD study protocol Q3: Continued FDA protocol discussions; advanced Abbott collaboration Maintained/progressed
Phase 3 LVAD trial (TECH-LVAD)2025Feb 3, 2025: FDA Type D meeting provided additional guidance; Abbott collaboration to support trial design/site identification/awareness (Mar 4, 2025) Advanced readiness

No numeric guidance (revenue, margins, OpEx, OI&E, tax rate, dividends) was provided in Q4 materials .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4/FY 2024)Trend
Regulatory/FDAODD for LVAD in Apr 2024; protocol development underway FDA protocol discussions in early Sept 2024 FY release references Feb 3, 2025 Type D meeting with further guidance Progressing engagement
Partnering (Abbott)Initiated collaborative effort (LVAD/HeartMate 3) Advanced collaboration discussions Formal collaboration announced post-period (Mar 4, 2025) Formalized support
Manufacturing/CDMOEngaged CDMOs Completed operational readiness for clinical supply per cGMP FY release confirms readiness for pivotal Phase 3 Ready for trial supply
FinancingCash balance $5.0M (6/30) Raised ATM $5.1M; warrants $4.7M; cash ~$11.3M (11/7) FY: ~$9.8M raised; cash $10.0M (12/31) Strengthened then normalized
Scientific AdvocacyARIES-HM3 analysis highlighted need for new VKA EACTS Summit presentation on TECH-LVAD protocol and tecarfarin data Increased visibility
Ecosystem/Professional OrgsJoined AC Forum Corporate Council (Oct) Continued AC Forum engagement cited Broader engagement

Note: No Q4 earnings call transcript found; themes synthesized from press releases and FY 8-K Exhibit 99.1 .

Management Commentary

  • “Momentum is building from our achievement of several critical milestones toward beginning a pivotal clinical trial to evaluate tecarfarin’s superiority to warfarin in LVAD patients.” — Quang X. Pham, CEO (Nov 7, 2024) .
  • “We have made significant progress with advancing our planned pivotal trial to evaluate tecarfarin’s effectiveness for LVAD patients, including collaborative efforts with Abbott.” — Quang Pham (Aug 7, 2024) .
  • “2024 for Cadrenal was a year of focus and laying the foundations for advancing tecarfarin into Phase 3 clinical development… Throughout 2025, our primary focus is on execution…” — Quang X. Pham (Mar 13, 2025 Exhibit 99.1) .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available, so Q&A themes and guidance clarifications cannot be assessed .

Estimates Context

  • Wall Street consensus estimates via S&P Global for Q4 2024 could not be retrieved due to access limits; therefore, comparisons to consensus EPS and revenue are unavailable at this time. If accessible, values would be retrieved from S&P Global and used as the anchor for comparisons.

Key Takeaways for Investors

  • Funding runway improved into and through Q4 with ~$9.8M raised; year-end cash of $10.0M provides flexibility to progress trial readiness, though burn (Q3 cash use $2.2M) suggests ongoing financing needs depending on Phase 3 timing .
  • Regulatory and ecosystem momentum continues: ongoing FDA engagement (Q3) and Type D meeting guidance (Feb 2025) de-risks trial design steps; AC Forum participation may aid clinician awareness and recruitment .
  • Abbott collaboration (Mar 2025) is a strategic validation and operational support for TECH-LVAD, potentially accelerating site selection and trial execution; watch for protocol finalization and trial initiation catalysts .
  • Operating scale-up is visible: FY G&A rose to $6.8M; investors should monitor OpEx trajectory and cash conversion as the pivotal program begins .
  • With no Q4 call and limited quarterly disclosures, stock may trade on regulatory/partnering headlines and financing events rather than near-term financial beats/misses; catalysts include protocol submission/acceptance, first patient in, and trial site announcements .
  • Scientific advocacy around tecarfarin’s potential benefits vs. warfarin in LVAD/renal impairment contexts is growing; continued data visibility (e.g., EACTS) can support investor confidence ahead of Phase 3 readouts .
  • Risk factors: development-stage status, rising payables, and absence of revenue; financing cadence and regulatory timelines remain key to de-risking the medium-term thesis .