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Cadrenal Therapeutics, Inc. (CVKD)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 EPS of $-1.31 beat Wall Street consensus of $-1.55 by $0.24; net loss widened modestly year over year to $-2.69M from $-2.41M, driven by higher G&A costs . EPS beat reflects lower operating expenses versus Q2 and slightly higher interest income . Estimates from S&P Global.*
  • Cash and cash equivalents fell to $3.86M at quarter-end (from $5.57M in Q2 and $7.34M in Q1), and management disclosed substantial doubt about going concern absent additional financing; ATM issuance continued post-quarter ($0.23M gross) .
  • Strategic expansion: acquired eXIthera’s IV and oral Factor XIa portfolio, including Phase 2–ready IV frunexian; tecarfarin cGMP manufacturing completed; active planning for Phase 2 studies in LVAD and dialysis settings .
  • No product revenue; single operating segment. Near-term catalysts hinge on financing and trial initiations (targeted 2026 starts); narrative skews to pipeline build versus P&L metrics .

What Went Well and What Went Wrong

What Went Well

  • Pipeline progress: completed tecarfarin drug product manufacturing to cGMP; ongoing prep for Phase 2 LVAD study with Abbott and dialysis Phase 2 planning . Quote: “Completed the manufacturing of tecarfarin drug product in accordance with current good manufacturing practices (cGMP)” .
  • Portfolio expansion: acquired frunexian (IV, Phase 2–ready Factor XIa inhibitor) and related assets, adding acute-care anticoagulation opportunities and China license linkage (Haisco) . Quote: “Frunexian is a first-in-class, Phase 2-ready IV Factor XIa inhibitor designed for acute care settings…” .
  • EPS beat vs consensus: $-1.31 vs $-1.55, aided by lower total operating expenses vs Q2 ($2.73M vs $3.73M) and interest income stability . Estimates from S&P Global.*

What Went Wrong

  • Liquidity pressure: cash dropped to $3.86M; net cash used in operations YTD was $10.03M; explicit going concern disclosure (need partnering/equity/debt) .
  • Expense intensity: G&A up 22% YoY in the quarter ($2.04M vs $1.67M) and up 73% YTD ($6.96M vs $4.01M), reflecting public company costs and stock comp; R&D up 29% YTD to $3.43M .
  • No formal financial guidance; revenue remains zero, limiting near-term fundamental catalysts. ATM reliance persists (Q3 YTD $3.83M net; post-Q3 ~$0.22M net) .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Net Loss ($USD)$-2,407,829 $-3,845,380 $-3,667,287 $-2,685,705
Diluted EPS ($USD)$-2.18 $-2.09 $-1.87 $-1.31
Total Operating Expenses ($USD)$2,459,958 $3,927,976 $3,734,291 $2,733,803
G&A Expense ($USD)$1,674,905 $2,254,577 $2,656,392 $2,044,937
R&D Expense ($USD)$784,646 $1,667,882 $1,077,498 $688,465
Interest & Dividend Income ($USD)$52,129 $82,596 $67,004 $48,098
Cash & Equivalents ($USD)$4,363,900 $7,336,072 $5,570,730 $3,860,082
Shares Outstanding (period-end)1,234,672 1,909,732 2,007,113 2,059,754

Notes: Company reported no product revenue and operates a single segment .

Segment Breakdown

SegmentDescriptionNotes
Single segmentBiopharma development (anticoagulation)No product revenue; CODM assesses at company-wide level

KPIs

KPIQ3 2024Q1 2025Q2 2025Q3 2025
Net Cash Used in Ops (YTD, $USD)$5,566,844 $10,031,707
ATM Proceeds (YTD, gross $USD)$1,635,777 $4,015,598 $4,015,598
ATM Proceeds (Post-Q3, gross $USD)$227,772
Equity-based Comp (Qtr $USD)$299,980 $473,384

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY/Q4 2025Not providedNot providedMaintained (no guidance)
OpEx / MarginsFY/Q4 2025Not providedNot providedMaintained (no guidance)
Clinical timelines2026–2027Targeting 2026 Phase 2 starts; 2027 registrationReiterated planning; contingent on financing and partnershipsMaintained (narrative only)

Earnings Call Themes & Trends

(No Q3 earnings call transcript available; investor conference presentation used for narrative trends.)

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
Tecarfarin CMC readinessTech transfer to U.S. CDMO; drug product manufactured; clinical readiness Completed cGMP drug product manufacturing; evaluating Phase 2 LVAD and dialysis Progressing; operational milestone achieved
LVAD collaborationAbbott collaboration announced; HeartMate 3 trial design support Ongoing support; LVAD Phase 2 targeted for later 2026 (presentation) Steady; planning continues
ESKD/dialysis strategyPlan to initiate dialysis transition study; site activation later 2025 Investigator discussions for multi-site dialysis Phase 2; first enrollment targeted 1H26 (presentation) Advancing design; timeline framed
Acute-care anticoagulation (FXIa)N/AAcquired frunexian (IV FXIa), Phase 2–ready; China license retained Portfolio expansion
Liquidity/financingATM usage; raised $3.83M net YTD Going concern disclosure; additional post-Q3 ATM $0.23M gross Deteriorating liquidity; continued capital raising
Regulatory environmentFDA Type D feedback (Q1); trial design guidance Government shutdown risk to FDA/SEC timelines disclosed Heightened external risk

Management Commentary

  • “We have uniquely positioned ourselves to address gaps in anticoagulation treatment of multiple indications through the development of two differentiated anticoagulants (tecarfarin and frunexian)…” — Quang X. Pham, Chairman & CEO .
  • “Our focus as we finish 2025 is the progression of tecarfarin into clinical applications where significant anticoagulation challenges exist.” — Quang X. Pham .
  • On frunexian: “Frunexian is a first-in-class, Phase 2-ready IV Factor XIa inhibitor designed for acute care settings…” .

Q&A Highlights

  • No Q3 earnings call transcript was filed. The Lytham Partners Fall 2025 presentation was prepared remarks; no Q&A transcript was provided in filings .
  • Management’s investor remarks emphasized trial design de‑risking and acute-care positioning for frunexian; timelines contingent on financing and operational readiness .

Estimates Context

  • Q3 2025 EPS: actual $-1.31 vs consensus $-1.55; beat by $0.24. Q2 2025 EPS: $-1.87 vs $-1.775; miss by $0.095. Q1 2025 EPS: $-2.09 vs $-2.15; beat by $0.06. Revenue consensus was $0 across periods.
MetricQ1 2025Q2 2025Q3 2025
Primary EPS Consensus Mean ($)-2.15*-1.775*-1.55*
Primary EPS Actual ($)-2.09 -1.87 -1.31
Revenue Consensus Mean ($)0.00*0.00*0.00*

Values retrieved from S&P Global.*

Implications: Street models for CVKD focus on EPS only (no revenue). Q3 beat reflects lower operating expenses versus Q2; however, ongoing financing needs and increasing G&A suggest estimates may need to reflect higher dilution and expense run-rate until trials commence .

Key Takeaways for Investors

  • Liquidity is the gating factor: $3.86M cash and explicit going concern language increase near-term financing risk; expect continued ATM usage or partnering before trial initiations .
  • EPS beat in Q3 is not revenue-driven; operating expense control and interest income supported optics, but sustainability hinges on funding and pipeline milestones .
  • Strategic optionality broadened: frunexian acquisition adds acute-care FXIa exposure with Phase 2–ready asset and China licensing economics; clinical milestone payments are contingent and not yet recognized .
  • Tecarfarin is trial-ready operationally (cGMP product), with LVAD/ESKD pathways and regulatory design guidance; 2026 Phase 2 timelines require capital .
  • Watch external regulatory risks: disclosed government shutdown impacts across FDA/SEC could delay filings, financings, and trial starts .
  • Equity overhang/dilution risk persists given ATM activity and warrant overhang (615,940 warrants outstanding) .
  • Near-term catalysts: partnering announcements, financing updates, trial initiations/IRB/site activation, and FXIa program formulation progress. Absent these, stock narrative remains funding-driven.

Appendix: Additional Q2/Q1 Highlights (for trend context)

  • Q2 2025: Net loss $-3.67M; G&A $2.66M vs $1.21M prior-year; cash $5.57M; announced dialysis transition study plan; cGMP manufacturing progress .
  • Q1 2025: Net loss $-3.85M; G&A $2.25M; cash $7.34M; FDA Type D meeting guidance; Abbott collaboration for LVAD trial design .

Sources: Q3 2025 8-K press release and attached financials , Q3 2025 10-Q , Q2/Q1 8-Ks , Lytham Partners investor presentation transcripts .