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WINDTREE THERAPEUTICS INC /DE/ (WINT)·Q3 2024 Earnings Summary

Executive Summary

  • Windtree’s Q3 2024 was operationally steady with operating loss of $4.7M and net loss to common of $3.8M ($4.23 EPS), improving sequentially vs Q2 as non-cash R&D and financing-related items normalized .
  • Clinical execution was the bright spot: SEISMiC Extension Phase 2b met its primary endpoint (SBP AUC over 6 hours) with statistically significant and sustained BP improvements through 60 hours; secondary measures (cardiac output, PCWP, SVO2, renal function) also improved, with favorable safety profile and no increase in clinically significant arrhythmias, positioning the asset for Phase 3 planning .
  • Liquidity improved modestly: cash rose to $2.3M at 9/30; subsequent ELOC sales added $2.4M net, extending runway “through January 2025,” but current liabilities increased to $14.4M (incl. $8.6M warrant liability), underscoring near-term financing needs and the importance of partnerships .
  • Near-term catalysts: SEISMiC C (SCAI Stage C) interim readout planned early Q2 2025; BD efforts to secure non-dilutive capital for cardiovascular platform; partner-led AHF Phase 3 start-up in APAC; patent estate expansion—all potential narrative and stock drivers .

What Went Well and What Went Wrong

  • What Went Well

    • SEISMiC Extension met primary endpoint and showed durable BP benefits (SBP AUC 6h and through 60h), with improvements in cardiac output, PCWP, SVO2, and renal function; safety/tolerability favorable and consistent with prior studies .
    • Management advanced global trial strategy: initiated SEISMiC C (SCAI Stage C) to bridge to Phase 3; expanded IP across major geographies; communicated clear interim data timing (early Q2 2025) .
    • Capital structure actions: July private placements plus ELOC provided cash and extinguished certain debt and Series B preferred, improving balance sheet flexibility for near-term operations .
    • Quote: “The third quarter of 2024 was marked with significant progress… we plan to accelerate enrollments… with a planned interim data read out in early Q2 2025” – Craig Fraser, CEO .

  • What Went Wrong

    • Balance sheet still tight: cash/cash equivalents of $2.3M vs current liabilities of $14.4M (incl. $8.6M warrant liability); runway only through January 2025 even after ELOC draws—necessitating continued financing/BD .
    • Nasdaq compliance issue arose due to 10-Q filing delay (subsequently cured), highlighting execution risk on reporting cadence .
    • Operating losses persist (Q3 op loss $4.7M) with limited visibility to revenue near-term; Q2 had elevated non-cash R&D tied to Varian asset; sustainability depends on timely BD/non-dilutive funding .

Financial Results

  • Income statement and cash/liquidity trend
Metric (USD Millions, except per-share and shares)Q1 2024Q2 2024Q3 2024
Operating Loss$(4.41)$ $(11.45)$ $(4.74)$
Net Income (Loss) Attributable to Common$10.22$ $(12.02)$ $(3.75)$
Diluted EPS ($)$21.98$ $(20.91)$ $(4.23)$
R&D Expense$2.25$ $9.86$ $1.97$
G&A Expense$2.15$ $1.59$ $2.77$
Cash & Equivalents (end of period)$2.55$ $1.80$ $2.30$
Current Liabilities (end of period)$4.99$ $8.78$ $14.43$
Common Warrant Liability (incl. in current liab.)——$8.62$
Weighted Avg Shares (000s)465 575 887

  • Notes: Subsequent to 9/30, the company sold an additional 4.3M common shares under the ELOC for net proceeds of $2.4M; management believes resources fund operations through January 2025 . Q3 other income included $2.17M change in fair value of warrant liability .

  • KPIs (clinical, SEISMiC Extension – key readouts)

Endpoint (vs placebo)Resultp-value
SBP AUC 0–6h (combined Part A+B) (mmHg·hr)62.0 vs 36.40.0070
SBP AUC 0–6h (Part B only) (mmHg·hr)78.4 vs 39.60.0429
SBP AUC 0–24h (combined) (mmHg·hr)292.4 vs 190.90.0031
SBP AUC 0–24h (Part B) (mmHg·hr)299.3 vs 139.00.0377
SBP AUC 0–48h (Part B) (mmHg·hr)594.4 vs 271.70.0352
SBP AUC 0–60h (Part B) (mmHg·hr)711.4 vs 320.40.0408
PCWP reduction at 6h (mmHg)−6.6 vs −0.90.0001
Mixed venous O2 saturation (SVO2) at 12h~+9% vs placebo0.0071
Renal function (eGFR) at 48hImproved vs placebo0.0291
NYHA class (24/48/72h)Significant decrease0.020/0.035/0.010
Serious AEs: worsening HF (%)5.3% vs 18.2%descriptive

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
SEISMiC Extension toplineQ3 2024Expected by end of Q3 2024 Reported positive topline Sept 25/30, 2024 Achieved
SEISMiC C interim dataEarly Q2 2025Not previously datedInterim data planned early Q2 2025 New timing set (added specificity)
Capital runwayNear-termInsufficient 12-month runway; going concern cited; cash $1.8M at 6/30 Cash $2.3M at 9/30; post-Q3 ELOC net $2.4M; “through Jan 2025” Improved (short extension)
Nasdaq filing complianceNov 2024N/ALate 10-Q notice received Nov 21; cured Nov 26–27; matter closed Resolved

Earnings Call Themes & Trends

Note: No Q3 2024 earnings call transcript was available. We use Q2 PR/10-Q for prior mentions and the Oct 1, 2024 Investor Day transcript for the current period narrative.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3/Investor Day)Trend
Istaroxime clinical progressQ2: SEISMiC Extension to complete enrollment and topline by end Q3; SCAI C study start-up underway SEISMiC Extension met primary endpoint with robust BP, CO, PCWP, SVO2, renal benefits; SCAI C enrolling Positive execution; derisked efficacy
Regulatory/path to Phase 3 (shock)Q1/Q2: continued Phase 2b, planning; Fast Track in AHF noted Phase 3 planning enabled by SEISMiC; emphasis on favorable regulatory path in shock (BP correction primary) Clearer Phase 3 visibility
Partnering/BDQ1: Lee’s license for APAC and potential milestones/royalties Targeting regional/global partnerships; near-term “sweet spot” after Phase 2; co-promote optionality Intensifying BD push
Financing/liquidityQ1: Going concern; Q2: July financings/ELOC; cash tight Runway through Jan 2025 via ELOC sales; still needs capital/BD Short-runway; continued need
IPPre-existing patents (SERCA2a) Expanded patents in US/EU/Asia for istaroxime formulations Strengthening IP
AHF programQ1/Q2: APAC partner preparing Phase 3 in AHF Management reiterates APAC partner start-up; synergy with shock data External advancement

Management Commentary

  • Strategic posture: “Looking forward, we plan to accelerate enrollments in the istaroxime SCAI Stage C cardiogenic shock study with a planned interim data read out in early Q2 2025 … [and] turn attention to business development activities to secure additional licenses and partnerships … to secure non-dilutive capital” – Craig Fraser, CEO .
  • Clinical value proposition: “Istaroxime… may be the only drug candidate that has been shown to simultaneously improve blood pressure, cardiac output and renal function without increasing heart rate or risk for cardiac arrhythmias” – Prof. Alexandre Mebazaa (KOL) .
  • Investor Day framing: Favorable shock regulatory path anchored on BP correction; strong KOL enthusiasm; market ~$1.25B (US+EU ~$1.0B) for cardiogenic shock .
  • Commercial/BD approach: Pursue regional/global deals with co-promote rights; acute hospital launch model feasible for lean team; Phase 3 shock database “a couple of hundred patients,” clinical cost “under ~$20M” if partnered .

Q&A Highlights

  • Why lead with cardiogenic shock? Faster/less expensive regulatory path (BP correction), strong hospital reimbursement; AHF remains strategic but partner-funded .
  • Funding/partnering plan: Active BD discussions timed around end-of-Phase 2; aim for non-dilutive regional/global deals to share Phase 3 costs .
  • Commercialization strategy: Acute hospital-focused field force (tens of reps) or co-promotion with larger partner; retain optionality to become revenue-generating .
  • Phase 3 scope and cost: Expect “a couple of hundred patients” for safety database; clinical cost “under $20M” (contextual; dependent on partnerships) .

Estimates Context

  • Wall Street consensus (S&P Global) for WINT’s Q3 2024 EPS and revenue was unavailable at the time of query; we could not compare results to consensus. As a clinical-stage biotech with no product revenue, investor focus remains on opex cadence, runway, and clinical milestones .

Key Takeaways for Investors

  • Clinical momentum is strong: SEISMiC Extension hit primary and multiple secondary endpoints with favorable safety—materially de-risking the mechanism and Phase 3 planning in cardiogenic shock .
  • Near-term catalyst density: SEISMiC C interim in early Q2 2025, ongoing BD activity, and partner-led AHF Phase 3 preparations offer multiple narrative inflections .
  • Liquidity still constrained: Cash $2.3M at Q3-end and short runway (through Jan 2025 post-ELOC) keep financing/BD front-and-center; watch for licensing or additional capital actions .
  • Balance sheet optics: Current liabilities elevated by warrant liability; equity/equity-linked financing mix introduces volatility but has extended runway in the near term .
  • Strategic leverage: Expanded istaroxime IP, multi-asset CV platform (including oral SERCA2a activators) and APAC partnership increase optionality for non-dilutive funding .
  • Trading lens: Data credibility plus visible interim readout timing can support sentiment; however, funding overhang and execution (enrollment, BD timing) likely drive stock volatility until a partnership or larger financing is secured .

Additional Relevant Q3 2024 Press Releases (Context)

  • Completed enrollment in SEISMiC Extension (Sept 4) .
  • Positive topline from SEISMiC Extension (Sept 25) .
  • Detailed efficacy/safety topline including statistical outcomes (Sept 30) .
  • Investor Day announcement (Sept 26) and transcript (Oct 1) for themes, strategy, and Q&A .

Appendix: Source Documents

  • Q3 2024 earnings press release/8-K 2.02 (Nov 27, 2024) .
  • Q2 2024 press release (Aug 20, 2024) .
  • Q1 2024 Form 10-Q (May 15, 2024) for financial baselines and licensing context .
  • Other Q3 clinical/financing PRs (July–Sept 2024) .