Windtree Therapeutics : May'23 Corporate Presentation

Windtree Therapeutics

Company Overview

May 9, 2023

(NASDAQ: WINT)

Forward-Looking Statements

This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements, among other things, include statements about the Company's clinical development programs, business strategy, outlook, objectives, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's product development activities, or otherwise as to future events. The forward- looking statements provide our current expectations or forecasts of future events and financial performance and may be identified by the use of forward-looking terminology, including such terms as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "will," "should," "could," "targets," "projects," "contemplates," "predicts," "potential" or "continues" or, in each case, their negative, or other variations or comparable terminology, though the absence of these words does not necessarily mean that a statement is not forward-looking. We intend that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. These risks and uncertainties are further described in the Company's periodic filings with the Securities and Exchange Commission ("SEC"), including the Company's most recent reports on Form 10-K, and any subsequent quarterly reports on Form 10-Q and current reports on Form 8-K, and any amendments thereto ("Company Filings"). Moreover, we operate in an evolving environment. New risks and uncertainties may emerge from time to time, and it is not possible for management to predict all risks and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Under no circumstances shall this presentation be construed as an offer to sell or as a solicitation of an offer to buy any of the Company's securities. In addition, the information presented in this deck is qualified in its entirety by the Company Filings. The reader should refer to the Company Filings for a fuller discussion of the matters presented here.

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Windtree Therapeutics and Istaroxime Highlights

Biopharmaceutical company with advanced clinical focus on significant acute CV markets with high unmet needs and with supportive regulatory paths and designations (NASDAQ: WINT)

Through three Phase 2 global studies, lead asset istaroxime has consistently demonstrated a highly unique and attractive profile

• An acute heart failure and cardiogenic shock drug candidate that has demonstrated both significant improvement in cardiac function as well as rapid and significant improvement in blood pressure, with favorable effect on myocardial oxygen demand and renal function and what so far has been a differentiating safety profile (avoiding many of the use-limiting side effects of existing therapies)

Recent positive Phase 2 study with istaroxime in early cardiogenic shock (ECS) paves the way for what we believe is a relatively fast and less expensive developmental and regulatory pathway

• Precedent shows blood pressure response can be acceptable as the primary endpoint in a pivotal shock study. Additionally, istaroxime is demonstrating other significant benefits that we plan to build upon in the larger Phase 3 to create a strong, evidence-based clinical and pharmacoeconomic positioning

Highly engaged in business development activities - including exploring strategic opportunities

Lean, capital efficient operation led by a highly experienced management team

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Pipeline

Lead Products	Indication	Phase	Development Status	Regulatory Status
			• Positive Phase 2 study
Istaroxime	Cardiogenic Shock	Phase 2	• Planning the execution of the next study and plans to	Executed Phase 2 in
	meet with regulatory agencies regarding development	early cardiogenic shock,
				path
			• Augment AHF data with the efficacy, safety and
Istaroxime				dosing from the extension and other studies in the	FDA Fast Track
Acute Heart Failure	Phase 2b		severe AHF patients experiencing cardiogenic shock.
				If positive and adequate, move istaroxime into phase	Designation
				3 for AHF with partnership
Oral SERCA2a	Chronic Heart Failure, including	Preclinical	•	Chronic and Acute Heart Failure	IND-enabling studies
Activators	potentially HFpEF	•	Target for collaboration/partnership
			• Phase 2 data in hypertension and genetically
Rostafuroxin	Treatment Resistant			associated hypertension	Ex-U.S. filings
Hypertension - Genetically	Phase 2b	• Company repositioned for the attractive and large
Open U.S. IND
	Associated			Resistant Hypertension market
			• Out-licensing opportunity
KL4 Surfactant	KL4 surfactant Drug/Device Tx		• Global out-license to Lee's Pharmaceuticals	FDA Fast Track
for RDS and potential other	Phase 2b	Designation, Orphan
and AEROSURF
applications				Drug

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Istaroxime

Cardiogenic Shock

Potential indication in active clinical development

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