Executive Summary

Q1 2024 printed a headline net income of $10.2M ($21.98 per share), entirely driven by a $14.5M non‑cash gain from extinguishing a $15.0M Deerfield milestone liability; core operations remained loss‑making with $4.4M operating loss and no reported revenue .
Liquidity tightened: cash and equivalents fell to $2.55M from $4.32M QoQ, current liabilities rose to $4.99M, and management disclosed substantial doubt about going concern with runway only through mid‑May 2024 absent new capital .
Execution continued on cardiogenic shock: SEISMiC Extension (Stage B) and SEISMiC C (Stage C) trials are ongoing with data anticipated 2H 2024, though sample sizes depend on securing resources .
Strategic moves: eliminated Deerfield milestone overhang; signed a Greater China cardiovascular license with Lee’s (HK); amended CRO terms with MRI to cap near‑term cash outlay; and acquired an aPKCi inhibitor platform, adding an oncology option to the pipeline .
No Q1 earnings press release or call transcript was found; no formal financial guidance was issued. Wall Street consensus from S&P Global for Q1 was unavailable, so no estimate comparison was possible .

What Went Well and What Went Wrong

What Went Well

Eliminated $15.0M contingent milestone liability to Deerfield via $0.2M cash plus 33,793 shares, booking a $14.5M non‑cash gain; this removed a long‑standing balance‑sheet overhang and created Q1 net income .
Regional partnering momentum: executed a Greater China license with Lee’s (HK) (cardiovascular portfolio), eligible for up to $3.1M development milestones and $135.25M sales milestones plus royalties; Windtree retains ex‑territory rights and gains access to partner‑generated IP .
Management message on portfolio strategy and capital efficiency: “We plan to read out data from both of our ongoing Phase 2 istaroxime trials in cardiogenic shock… We are actively engaged in global partnership discussions for istaroxime… by adding the innovative aPKCi inhibitor platform… we plan to strengthen our focus on advancing our preclinical programs” — Craig Fraser, CEO .

What Went Wrong

Liquidity/going concern: cash declined to $2.55M with current liabilities of $4.99M; management stated runway only through mid‑May 2024 and “substantial doubt” absent financing/transactions .
Elevated R&D burn in cardiogenic shock: Q1 R&D rose to $2.25M (from $1.42M YoY) driven by SEISMiC Extension and Stage C study activity, despite G&A discipline being mixed QoQ .
Financing constraints and overhangs: new 10% senior convertible notes and 10% dividend Series B preferred add potential dilution and cash claims; reverse split was required to restore Nasdaq compliance .

Financial Results

Income statement and key items (oldest → newest)

Metric	Q3 2023	Q4 2023	Q1 2024
Revenue ($MM)	$0.0	$0.0	$0.0
R&D Expense ($MM)	$2.11	$3.05	$2.25
G&A Expense ($MM)	$2.58	$1.91	$2.15
Operating Income (Loss) ($MM)	$(4.69)	$(4.96)	$(4.41)
Gain on Debt Extinguishment ($MM)	$0.00	$0.00	$14.52
Net Income (Loss) ($MM)	$(4.43)	$(5.15)	$10.22
Diluted EPS ($)	$(0.86)	$(0.95)	$21.98

Notes: Company reports no revenue; operating costs drive operating losses; Q1 2024 EPS inflated by non‑recurring $14.5M gain on extinguishment .

Balance sheet (QoQ)

Metric	Dec 31, 2023	Mar 31, 2024
Cash & Equivalents ($MM)	$4.32	$2.55
Current Liabilities ($MM)	$3.996	$4.985
Total Liabilities ($MM)	$29.02	$14.68
Stockholders’ Equity ($MM)	$3.39	$15.42
Restructured Debt Liability (Deerfield) ($MM)	$15.00	$0.00

R&D program mix (Q1 YoY)

R&D Detail ($MM)	Q1 2023	Q1 2024
Istaroxime – Cardiogenic Shock	$0.42	$1.48
Istaroxime – AHF	$(0.02)	$0.00
KL4 Surfactant	$(0.08)	$0.00
Product Dev & Manufacturing	$0.25	$0.22
Clinical/Medical/Regulatory Ops	$0.85	$0.55
Total R&D	$1.42	$2.25

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Financial guidance (revenue/EPS/OpEx)	FY/Q2 onward	None	None	Maintained (no formal guidance)
Clinical timelines	2024	SEISMiC Extension/C in‑flight	Data expected 2H 2024; completion dependent on funding	Reiterated with funding caveat

Earnings Call Themes & Trends

No Q1 2024 earnings call transcript was found; themes synthesized from the 10‑Q and April 17 business update press release.

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q1 2024)	Trend
Funding & Going Concern	Q3: runway through Q1’24; substantial doubt . Q4: runway through April ’24 .	Runway through mid‑May ’24; substantial doubt persists; pursuing equity/debt/BD .	Unchanged pressure; incremental financings but tight liquidity.
Cardiogenic Shock Trials	Q3: planned SEISMiC Extension and Stage C start‑up . Q4: first subject enrolled in Extension; Stage C initiated; results 2H’24 .	Both trials ongoing; 2H’24 data; completion depends on resources .	Advancing; resource‑dependent.
Partnering/Licensing	Q3: pursuing licensing; support Lee’s in China . Q4: announced Greater China license intent .	Executed Lee’s license; detailed milestones/royalties; reciprocal IP rights .	Strengthening regional footprint.
Capital Structure Actions	Q3: $10.8M raise; ATM in place . Q4: plan to remove Deerfield overhang .	Deerfield extinguished; issued 10% notes; 10% Series B pref; 1‑for‑18 reverse split; regained Nasdaq .	De‑risked liability; added potential dilution/cost of capital.
Cost Management/CRO	—	MRI amendment: $1.2M scheduled payments; 2% economic share on istaroxime deals/sales; services continue to completion .	Structuring CRO cash outlays; limited royalty‑like tail.
Pipeline Expansion	—	Acquired aPKCi inhibitor platform (topical/oral) with 10% pref dividend structure to creditors .	Optionality beyond cardiovascular.

Management Commentary

“Later this year, we plan to read out data from both of our ongoing Phase 2 istaroxime trials in cardiogenic shock… we are actively engaged in global partnership discussions for istaroxime…” — Craig Fraser, CEO .
“We progressed clinical execution of the SEISMiC Extension Study… initiated a study of istaroxime in more severe SCAI Stage C cardiogenic shock… We plan to progress the IND‑enabling activities for a topical and oral [aPKCi] formulation…” — Dr. Steve Simonson, CMO .

Q&A Highlights

No Q1 2024 earnings call transcript or Q&A was found in company documents; no clarifications provided beyond the 10‑Q and April 17 business update .

Estimates Context

S&P Global/Capital IQ consensus estimates for Q1 2024 (revenue, EPS) were unavailable via our data service at this time, so a comparison to Street expectations cannot be provided. Results were heavily influenced by a non‑recurring $14.5M gain on debt extinguishment, making EPS not reflective of core performance .

Key Takeaways for Investors

Core P&L unchanged: no revenue, operating loss of $4.4M; Q1 profit was entirely non‑recurring from Deerfield extinguishment — avoid extrapolating EPS run‑rate from Q1 .
Liquidity is the gating factor: $2.55M cash vs $4.99M current liabilities and a disclosed going‑concern warning; near‑term financings or BD inflows are critical in Q2 .
Clinical catalysts in 2H 2024 (SEISMiC Extension and Stage C) could be stock‑moving, but enrollment and completion depend on resourcing; monitor funding updates and MRI deliverables .
Strategic de‑risking: removal of $15M Deerfield liability and MRI settlement reduce structural overhangs, though MRI adds a 2% economic share on future istaroxime deal value/sales .
Dilution risk persists: 10% senior convertibles, 10% dividend Series B preferred, and prospective equity issuance/ATM usage remain likely funding paths despite regained Nasdaq compliance .
Partnering optionality: Greater China deal with Lee’s (HK) provides a credible regional pathway and potential milestone/royalty upside; global out‑licensing of istaroxime remains a high‑impact swing factor .
Pipeline breadth: aPKCi acquisition introduces oncology upside optionality but also adds development spend; prioritization and external funding/partnerships will be key to avoid over‑extension .

Appendices

Additional Q1 operational/liquidity details (selected)

PMUSA/PMPSA license amendments: upfronts paid in January; ~$0.7M remaining current liability as of March 31, 2024 .
ATM activity: sold ~143k shares in Q1 for ~$1.37M net .
Reverse split 1‑for‑18 effected April 19, 2024; Nasdaq compliance restored May 6, 2024 .

Document discovery notes

No Q1 2024 8‑K Item 2.02 earnings press release or Q1 call transcript was available in the document set; primary source for quarter results is the Form 10‑Q filed May 15, 2024 . The April 17, 2024 8‑K covered Q4 and year‑end updates and strategic items .

WINDTREE THERAPEUTICS INC /DE/ (WINT)·Q1 2024 Earnings Summary