Executive Summary

Q2 2024 showed a larger operating and net loss driven by a $7.5M non-cash R&D expense tied to the Varian oncology asset acquisition; operating loss was $11.5M (vs. $6.8M in Q2 2023) and net loss was $12.0M (EPS -$20.91) (vs. $6.6M, EPS -$29.47 YoY) .
Liquidity remained tight at quarter-end (cash and cash equivalents $1.8M; current liabilities $8.8M) with going concern disclosure; subsequent July transactions provided ~$13.9M gross proceeds (including $4.4M new funding and $9.5M extinguishment) and an equity line facility up to the lesser of $35M or 19.99% of shares outstanding to potentially support future needs .
Clinical execution on istaroxime: SEISMiC Extension topline data targeted by end of Q3 2024; acceleration of Stage C cardiogenic shock enrollment; partnership support for Lee’s planned Phase 3 in acute heart failure; oncology (aPKCi) strategy update expected in the coming months .
Q1 2024 was positively skewed by a $14.5M non-cash gain on debt extinguishment (net income $10.2M, EPS $21.98), underscoring volatility in reported results due to financing actions rather than operations .
Wall Street consensus via S&P Global was unavailable for Q2 2024; no call transcript found, so estimate comparisons and Q&A highlights are limited [GetEstimates error] [ListDocuments earnings-call-transcript=0].

What Went Well and What Went Wrong

What Went Well

Advanced clinical timelines: “We expect the istaroxime Phase 2 SEISMiC Extension study to complete enrollment in the next few weeks and… report topline data by the end of the third quarter of 2024” .
Strengthened capital structure: Closed July transactions for ~$13.9M gross proceeds, including $9.5M of senior notes and Series B preferred cancellation and $4.4M new funding; also secured an equity line with capacity up to the lesser of $35M or 19.99% of shares outstanding .
Governance depth: Added two independent directors (Saundra Pelletier and Jed Latkin) with public company and drug development expertise at a pivotal time .

What Went Wrong

Cash constraints and going concern: Cash fell to $1.8M vs. current liabilities of $8.8M; management disclosed substantial doubt about ability to continue as a going concern absent additional funding .
Increased operating loss: Operating loss widened to $11.5M in Q2 2024 (vs. $6.8M YoY), primarily due to the $7.5M non-cash R&D expense tied to the Varian acquisition .
No earnings call transcript and limited analyst coverage: Lack of a transcript and unavailable S&P Global consensus impeded broader investor dialogue and estimate benchmarking [ListDocuments earnings-call-transcript=0] [GetEstimates error].

Financial Results

Metric	Q2 2023	Q1 2024	Q2 2024
R&D Expense ($USD Millions)	$1.76	$2.25	$9.86
G&A Expense ($USD Millions)	$2.42	$2.15	$1.59
Operating Loss ($USD Millions)	$(6.76)	$(4.41)	$(11.45)
Net Income (Loss) ($USD Millions)	$(6.60)	$10.22	$(12.02)
Diluted EPS ($)	$(29.47)	$21.98	$(20.91)
Weighted Avg. Shares (000s)	520	465	575

KPIs and balance sheet:

Metric	Q1 2024	Q2 2024
Cash & Cash Equivalents ($USD Millions)	$2.55	$1.80
Current Liabilities ($USD Millions)	$4.99	$8.78

Notes:

Q2 2024 R&D included a $7.5M non-cash expense related to the Varian asset acquisition, an explicit driver of quarterly OPEX .
Q1 2024 net income was primarily due to a $14.5M gain on debt extinguishment, not core operations .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
SEISMiC Extension topline data timing	Q3 2024	“Data anticipated in 2H 2024”	“Report topline data by end of Q3 2024”	Clarified timing (narrowed to Q3)
SCAI Stage C (cardiogenic shock) enrollment	2024	“Enrollment anticipated to be completed in late 2024”	“Accelerate enrollments in SCAI Stage C study”	Raised pace (operational acceleration)
aPKCi oncology asset strategy	2024	“Advance IND-enabling activities; determine clinical plan”	“Provide guidance on strategy and planned activities”	Introduced formal guidance milestone

Earnings Call Themes & Trends

No Q2 2024 earnings call transcript was found; themes are derived from filings/press release.

Topic	Previous Mentions (Q1 2024)	Current Period (Q2 2024)	Trend
Clinical milestones (istaroxime)	SEISMiC Extension and C studies; data 2H 2024; Stage C completion late 2024	SEISMiC Extension topline by end Q3; accelerate Stage C enrollment	Execution tightening; accelerated pace
Financing/liquidity	ATM usage; reverse split; senior notes; going concern	~$13.9M July transactions; equity line up to lesser of $35M or 19.99%	Liquidity options broadened
Strategic/Board	Program prioritization; Varian aPKCi acquisition	Added independent directors Pelletier, Latkin; oncology strategy update planned	Governance depth; oncology visibility
Partnering (Lee’s)	Support for planned AHF Phase 3 in China	Continued support noted	Steady engagement

Management Commentary

“The second quarter of 2024 was marked with significant progress with our lead asset, istaroxime… We expect the istaroxime Phase 2 SEISMiC Extension study to complete enrollment in the next few weeks and we plan to report topline data by the end of the third quarter of 2024.” – Craig Fraser, Chairman & CEO .
“We… successfully completed transactions providing resources for our near-term needs as well as secured an equity line of credit to potentially support future requirements.” – Craig Fraser .
“We are excited about our two new independent board directors… who have joined our Board at a pivotal time.” – Craig Fraser .

Q&A Highlights

No Q2 2024 earnings call transcript was available; therefore, Q&A themes and clarifications could not be assessed [ListDocuments earnings-call-transcript=0].

Estimates Context

S&P Global/Capital IQ consensus estimates for Q2 2024 EPS and revenue were unavailable (tool returned daily limit exceeded error), and there was insufficient published coverage to benchmark results vs. Street. As a result, we cannot assess beats/misses vs. consensus this quarter [GetEstimates error].

Key Takeaways for Investors

Non-cash R&D elevated: The $7.5M non-cash R&D expense from the Varian aPKCi acquisition significantly increased Q2 operating loss; normalize OPEX run-rate when evaluating go-forward burn .
Liquidity remains the core risk: Quarter-end cash $1.8M and going concern disclosure highlight financing risk; subsequent ~$13.9M actions and the equity line improve near-term runway but execution pace will still depend on timely capital access .
Near-term catalyst: SEISMiC Extension topline by end of Q3 2024 is the primary clinical event; positive data could be a stock driver and support partnering discussions .
Cardiogenic shock program acceleration: Explicit focus on enrollment acceleration in Stage C shock suggests increased operational tempo; watch for site activation and enrollment metrics .
Oncology optionality: Expect near-term strategy guidance on aPKCi inhibitor platform; could broaden non-cardiac pipeline visibility and partnering avenues .
Partnership leverage: Continued support for Lee’s planned AHF Phase 3 may provide external validation; global partnership options remain relevant for funding and execution .
Volatile reported EPS: Q1’s debt extinguishment gain and Q2’s non-cash R&D show results heavily influenced by financing/accounting items; focus on cash burn, clinical timelines, and financing developments .

Appendices

Additional Operating Detail (from Press Release)

Research and development expenses: $9.9M in Q2 2024 vs. $1.8M Q2 2023; increase driven primarily by $7.5M non-cash R&D from Varian asset acquisition and $1.0M higher SEISMiC Extension trial costs, partially offset by $0.4M lower personnel costs .
General and administrative expenses: $1.6M in Q2 2024 vs. $2.4M Q2 2023; decreases across professional fees, personnel costs, stock-based compensation, and insurance .
Net loss: $12.0M in Q2 2024 (EPS -$20.91) vs. $6.6M in Q2 2023 (EPS -$29.47) .
Cash and current liabilities: Cash & equivalents $1.8M; current liabilities $8.8M at June 30, 2024 .
Financing updates: July 2024 transactions with ~$13.9M aggregate gross proceeds and equity line capacity up to the lesser of $35M or 19.99% of shares outstanding; board changes (Pelletier, Latkin) .

WINDTREE THERAPEUTICS INC /DE/ (WINT)·Q2 2024 Earnings Summary