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WT

WINDTREE THERAPEUTICS INC /DE/ (WINT)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was operationally focused with no product revenue; Windtree reported net loss of $4.0M and basic/diluted EPS of $(4.63), alongside a decreased operating loss versus prior year and lower G&A expenses .
  • Management advanced a new corporate strategy to become a revenue-generating company via acquisition of FDA-approved assets and initiated a strategic transaction granting rights to purchase a 436-unit multifamily property; regained Nasdaq minimum bid price compliance .
  • R&D execution continued: enrollment progressed in the SEISMiC C Phase 2 cardiogenic shock study (interim analysis of first 20 subjects planned for Q3 2025; press guidance later targeted July 2025) and multiple IP updates, including U.S. exclusivity strategy (NCE + 7.5-year stay) for istaroxime .
  • Liquidity remains tight: cash and cash equivalents were $1.2M at quarter-end and management guided resources sufficient through May 2025; subsequent preferred financing raised ~$2.6M gross in April/May .
  • Upcoming catalysts that may drive stock reaction: SEISMiC C interim data in Q3 2025, potential out-licensing/partnerships, and execution on revenue-generating strategy (including Evofem sourcing deal and China partnership with anticipated revenues by end of 2026) .

What Went Well and What Went Wrong

What Went Well

  • New corporate strategy to become revenue-generating while advancing pipeline; “We believe that this strategy has the potential to transform Windtree into both a commercial and development stage company...” — CEO Jed Latkin .
  • R&D progress: SEISMiC C cardiogenic shock Phase 2 enrollment ongoing with interim analysis planned in Q3 2025; continued global IP expansion and NCE exclusivity strategy highlighted .
  • Operating discipline: Operating loss narrowed YoY ($4.1M in Q1’25 vs $4.4M in Q1’24) and G&A decreased to $1.8M (from $2.1M) on lower professional fees and stock-based comp .

What Went Wrong

  • No product revenue and continued net loss ($4.0M) with cash of $1.2M and runway only through May 2025, underscoring funding risk .
  • Shareholder dilution and capital structure complexity persisted: dividends on Series C preferred ($1.0M) increased loss attributable to common stockholders to $5.0M .
  • Liquidity constraints remain a headwind; while the company regained Nasdaq minimum bid compliance, it is still under panel monitoring through March 2026 .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Revenues ($USD Millions)N/AN/AN/A
Net Income - (IS) ($USD Millions)$(2.749) $2.767*$(4.045)
EPS (Basic & Diluted, $)$(4.23) $0.396*$(4.63)
R&D Expense ($USD Millions)$1.968 N/A$2.270
G&A Expense ($USD Millions)$2.773 N/A$1.820
Total Operating Expenses ($USD Millions)$4.741 $3.921*$4.090
Cash and Cash Equivalents ($USD Millions)$2.300 $1.779 $1.173
Current Liabilities ($USD Millions)$14.426 $5.717 $6.476

Note: Asterisk values retrieved from S&P Global.*

Estimate comparison

MetricQ1 2025 ConsensusQ1 2025 ActualVariance
Revenue ($USD Millions)N/AN/AN/A
EPS ($)N/A$(4.63) N/A

Wall Street consensus (S&P Global) not available for WINT’s Q1 2025; no estimate counts returned.

KPIs

KPIQ3 2024Q4 2024Q1 2025
Operating Loss ($USD Millions)$(4.741) N/A$(4.090)
Dividends on Series C Preferred ($USD Millions)$(1.573) N/A$(0.998)
Weighted Avg Shares (Basic/Diluted)0.887M 0.053M 1.089M
Cash Runway CommentarySufficient through Jan 2025 Sufficient through Apr 2025 Sufficient through May 2025

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Liquidity runwayNear-termSufficient through Apr 2025 Sufficient through May 2025 Maintained with slight extension
SEISMiC C interim analysis timingQ3 2025 (first 20 pts)Early Q3 2025 Targeted July 2025 Clarified timeline
SEISMiC C program path2025-2026Advance program based on interim Completion of Phase 2b intended to progress to Phase 3; regulatory discussions early 2026 Maintained
Revenue generation from China partnershipBy end of 2026Not previously providedAnticipate partnership revenue by end of 2026 New
Strategic transaction (multifamily property right-to-buy)2025+Not previously providedRights to purchase 436-unit property; potential consistent revenue New
Nasdaq listing statusThrough Mar 2026Out of compliance in Nov 2024 Regained compliance; panel monitor until Mar 20, 2026 Improved / maintained compliance oversight

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript found for WINT; Q&A detail unavailable.

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Corporate strategy to become revenue-generatingEmphasis on BD/licensing for cardiovascular assets Formalized revenue-generating biotech strategy for 2025 Executing strategy; real estate right-to-buy, Evofem sourcing partner Accelerating execution
Cardiogenic shock (istaroxime)Positive Phase 2b topline; initiation of SEISMiC C Continued SEISMiC C start; plan interim assessment in Q3 2025 Interim analysis plan reaffirmed; timing clarified to July 2025 Advancing toward Phase 3
IP/ExclusivityExpanded patents across geographies National phase filings; AHF patent allowance NCE-based exclusivity strategy in U.S. (7.5-year stay) Strengthening IP moat
Financing/LiquidityJuly 2024 financings; ELOC established Additional financings post YE; runway through Apr 2025 Series D preferred ~$2.6M gross; runway through May 2025 Ongoing capital raises
Partnerships/ChinaLee’s Pharma Phase 3 support Greater China licensing progressing China partner cost-of-production reduction (~65%), revenue expected end-2026 Deepening partnerships

Management Commentary

  • “We announced our new corporate strategy to become a revenue generating company by seeking to identify and acquire revenue-generating FDA-approved assets while advancing our cardiology and oncology pipeline.” — CEO Jed Latkin .
  • “Leveraging off our firm partnership in China we are helping a rapidly growing biopharmaceutical company lower their costs of production by almost 65%... We anticipate the partnership should start generating revenues by the end of 2026.” — CEO Jed Latkin .
  • “We plan an interim analysis of the first 20 subjects in Q3 2025... intended to advance the program to Phase 3 in cardiogenic shock.” — CEO Jed Latkin .
  • “The interim data from the SEISMiC C Study are very important... completion of the SEISMiC C Study is an important milestone to move steadily toward Phase 3.” — CMO Dr. Steve Simonson .
  • “Istaroxime may receive New Chemical Entity (NCE) designation... entitled to 5 years of data exclusivity, and a stay... equal to 7.5 years from the date of FDA approval...” — CEO Jed Latkin .

Q&A Highlights

  • No earnings call transcript available for Q1 2025; Q&A themes and guidance clarifications not accessible for this quarter.

Estimates Context

  • S&P Global consensus for Q1 2025 EPS and revenue was unavailable (no estimates returned), preventing beat/miss analysis. Actual EPS was $(4.63) versus no published consensus, and revenue was not reported in Q1 2025 .

Key Takeaways for Investors

  • Liquidity risk persists: $1.2M cash and runway only through May 2025 at quarter-end; subsequent preferred financing helps but continued capital access is critical .
  • Pipeline momentum in cardiogenic shock: SEISMiC C interim data in Q3 2025 (targeted July) is the key binary catalyst toward Phase 3 and future partnering/regulatory pathways .
  • IP and exclusivity strategy strengthens potential U.S. commercialization prospects for istaroxime (NCE + 7.5-year stay upon approval) .
  • Strategic pivot to revenue generation is tangible: Evofem sourcing agreement and China partnership (cost reduction ~65%, revenue expected by end-2026) broaden non-dilutive potential, though execution risk remains .
  • Operating discipline notable: YoY operating loss improved and G&A reduced; however, absent product revenue and preferred dividends elevate loss to common shareholders, requiring careful capital structure management .
  • Stock catalysts: SEISMiC C interim readout, licensing/out-licensing deals, further IP milestones, and visible progress on revenue-generating initiatives may drive sentiment and liquidity.
  • Medium-term thesis: If interim data confirm efficacy/safety in SCAI Stage C and partnering advances, de-risking toward Phase 3 plus enhanced exclusivity and strategic revenue streams could improve funding optionality and valuation; execution and financing are the gating factors .

Additional relevant press releases supporting Q1 2025 context:

  • Presentation of SEISMiC Extension data at ESC HF 2025 .
  • Preclinical arrhythmia-reduction data for istaroxime/SERCA2a activators .
  • Cardiogenic shock program and interim timing update .

Prior quarter references:

  • Q3 2024 results and SEISMiC topline/financing updates .
  • Year-end 2024 overview (strategy, IP, liquidity, commercialization path) .