Windtree Therapeutics, Inc. · OTC:WINT
Windtree Therapeutics — Investor Presentation (November 2023)
31 slides from Windtree Therapeutics's investor presentation, Nov 9, 2023
Slide 1: Windtree Therapeutics Company Overview
Windtree Therapeutics N Company Overview November 2023 Se i) WINDTREE (NASDAQ: WINT)
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation includes forward-looking statements within the meaning of Section 27Aof the Securities Actof 1933, as amended, and Section 21E ofthe Securities Exchange Act of 1934, as amended. These statements, among other things, include statements about the ‘Company's
Slide 3: Investment Highlights
Investment Highlights WINDTREE THERAPEUTICS vo Clinical stage biopharmaceutical company focused on acute cardiovascular critical conditions with advanced stage programs intended to address large markets with significant unmet needs (NASDAQ: WINT) Firstin class, novel lead asset istaroxime has demons
Slide 4: Multi-Asset / Indication Pipeline with Several Near-Term Milestones
Multi-Asset / Indication Pipeline with Several Near-Term Milestones Cardiogenic Shock with Istaroxime as Lead Program [acon Phas | Drslopment sti Pane Prony Program Lead program Positive Phase 2 study iie.t ees Executing small follow-on studies with planned Mid'24 read-outs intended to transition to
Slide 5: Istaroxime Milestones and Strategy for Value Creation
Istaroxime Milestones and Strategy for Value Creation 2023 2024 2025 Q3 Q4 Qi Q2 Q3 Q4 5 ” ss FDA @ _!staroxime Cardiogenic Shock tee cite Phase2 iC B Extension My Cardiogenic Shock ¢ SEISMIC suai Registration Study" Completedand ea Positive Results Istaroxime in Acute Heart Failure Seine Failure St
Slide 6: Istaroxime Cardiogenic Shock
Istaroxime Cardiogenic Shock Potential to transform the standard of care for critical patients
Slide 7: Cardiogenic Shock - A Critical Condition Caused by a Failing Heart
Cardiogenic Shock - A Critical Condition Caused by a Failing Heart A severe presentation of heart failure characterized by low blood pressure and inadequate blood flow to vital organs (hypoperfusion) accompanied by congestion and high filling pressures of the heart. It requires very urgent treatment
Slide 8: Significant Unmet Need and Reported Desire for Istaroxime
Significant Unmet Need and Reported Desire for Istaroxime + No satisfactory pharmacological intervention to reverse the conditions Available therapies have unwanted side effects such as risk for arrhythmias, decreasing blood pressure, renal dysfunction and even increases in mortality that limit thei
Slide 9: Istaroxime — Novel First-in-Class Therapy
Istaroxime — Novel First-in-Class Therapy Novel intravenous agent designed to improve systolic contraction and @® improves cardiac Relaxation via stimulation of SERCAZB actvty which enhances Calcium reuptake () Increases the Force of Contraction Via inhibition of the sodium-potassium pump ‘and effec
Slide 10: Istaroxime Cardiogenic Shock Program Came from AHF Phase Trials
Istaroxime Cardiogenic Shock Program Came from AHF Phase 2 Trials and the Potential Attractive Regulatory Pathway Phase 2a and 2b data in AHF - istaroxime uniquely and significantly improved: Cardiac Function + increased stroke volume + lowered cardiac filling pressures Systolic Blood Pressure Renal
Slide 11: SEISMiC Early Cardiogenic Shock Study
SEISMIC Early Cardiogenic Shock Study Clinical strategy: Start development with patients in early cardiogenic shock caused by severe heart failure eS frat es 8 WINDEREE 60 patients in early cardiogenic shock (SBP 75-90mmHg) with AHF Study drug was infused for 24 hours in a 1:1 randomization to place
Slide 12: Istaroxime Achieved Positive Primary Endpoint
Nie Istaroxime Achieved Positive Primary Endpoint Systolic Blood Pressure AUC through 6 Hours - mITT Population Bistaroxime BPlacebo mmHg) 9 ‘p= 0.017 ‘Change from Baseline in SBP () : : 0 os is 2 25 3 38 4 48 S$ SS 6 & Hours from Infusion Inititation WINDTREE ic
Slide 13: Systolic BP Improvements Persisted over 24 Hours
\ Secondary Results — Result: Systolic BP Improvements Persisted over 24 Hours Systolic Blood Pressure mITT Population 8 ~*Istaroxime © Placebo Change in SBP (mmHg) > t t { p=0.025 for AUC 0 2 24 Hours from Infusion Initiation 36 or WINDTREE cy
Slide 14: Cardiac Function Improvement
Cardiac Function Improvement Echocardiography demonstrated improvements in key systolic and diastolic cardiac function measures including: v Cardiac index (amount of output from the heart over a minute) significantly increased yv Stroke volume (amount of blood from the heart with each heartbeat) sub
Slide 15: Treatment was Associated with a Favorable Renal Profile
Treatment was Associated with a Favorable Renal Profile Renal function was not decreased in istaroxime treated patients Estimated Glomerular Filtration Rate miTT Population ‘change from Baseline in eGR (miimin/t.73m) Hours from infusion initiation WINDTREE ta choan ae mesnsangstancsa tors
Slide 16: Comparison of Doses
\ Comparison of Doses on of Do: 1.0 yg/kg/min Produced a Favorable Effect on SBP 1.0 ugikgimin dosing was associated with: * Early, rapid SBP increase and improvement in more echocardiographic assessments of cardiac function * More favorable adverse event, serious adverse event and clinical event pr
Slide 17: SEISMiC Study Results Summary
SEISMiC Study Results Summary v Systolic blood pressure significantly increased within the first 6 hours of initiating the infusion (p=0.017) and the increase was maintained throughout the 24-hour infusion (p=0.025) » SBP increases were rapid within the first hour and sustained through the 96-hour p
Slide 18: Cardiogenic Shock Development Strategy
Cardiogenic Shock Development Strategy Focus on thoroughness, speed and relatively low cost of trials SEISMIC Extension Study * Extended and titrated dosing for optimization = Additional characterization SEISMIC erseae ee —_ Study Data expected mia-2024 * Execute EOP2 meeting = Completed, positive S
Slide 19: Istaroxime Cardiogenic Shock Studies
Istaroxime Cardiogenic Shock Studies Expected Steps to Phase 3 Readiness Dose Optimization — Extension Study Study Objectives: associated with longer istaroxime dosing as well as evaluate a dose titration * More fully illuminate the effects and potential benefits associated with SERCA2a activation *
Slide 20: Cardiogenic Shock Represents a Significant Opportunity for Istaroxime and Windtree
Cardiogenic Shock Represents a Significant Opportunity for Istaroxime and Windtree ___ Significant opportunity for Istaroxime to make a difference: = ~30-40% mortality in classic shock and high morbidity = Very long average length of hospital stay (~ 19.5 days?) means high cost of hospital care (est
Slide 21: Istaroxime Acute Heart Failure
Istaroxime Dual Mechanism SERCA2a Activator Acute Heart Failure
Slide 22: Heart Failure — A Large and Growing Market with Significant Mortality and Unmet Need
Heart Failure — A Large and Growing Market with Significant Mortality and Unmet Need Annual Admissions Patients #1 cause of U.S. ae hospitalization ~1.3M us. Fil 7TMus in patients re + > 65 years old 1.5M cv. 25M + worawide ~7% ep grsisB Go & In-patient mortality annual U.S. hospital costs New pharm
Slide 23: Acute Heart Failure — Significant Unmet Clinical Need
Acute Heart Failure — Significant Unmet Clinical Need tient Management Goals Current Treatment Options * Clinical objectives for AHF » Current approaches to acutely improve cardiac patient management include: function are associated with unwanted effects: Relieve pulmonary Heart rhythm disturbances
Slide 24: Istaroxime AHF Phase 2a & 2b Studies
Istaroxime AHF Phase 2a & 2b Studies s @ Phase 2a n=120 Dosing= 6 hour ADHF Patients 0.5, 1, 1.5 ugikgimin Infusion Phase n=120 Dosing= 24 hour ADHF Patients 0.5, 1.0 vokaimin Infusion 2b (ayspnea pus need forlv furosemide > 40mQ) + Primary: PCWP significantly improved + Stroke Vol & SBP ~ significa
Slide 25: Istaroxime in AHF Phase 2b — Results Summary
Istaroxime in AHF Phase 2b — Results Summary Cardiac Function Improved with Both Doses + Lowered cardiac filling pressures A Increased in Systolic Blood Pressure ty es Increased Renal Function (eGFR) Heart Rate Decreased pla asad tA Favorable Heart Rhythm Profile Observed + No increase in clinically
Slide 26: Istaroxime — Acute Heart Failure
NEE Istaroxime — Acute Heart Failure Objective: Evaluate potential Phase 3 AHF program based on data from our cardiogenic shock program Potential Phase 3 AHF Program Augment our data from the positive phase 2a and phase 2b AHF studies with the efficacy, safety and dosing and characterization learnin
Slide 27: Next Generation, Oral SERCA2a Activators
Next Generation, Oral SERCA2a Activators Acute and Chronic Heart Failure Platform The Company also has pre-clinical programs on product candidates including: Pure SERCA2a Dual Mechanism, (SERCA2a & Na+/K+) Activators Compounds + Potential Oral & i.v. therapies for + “Next generation istaroxime’ as o
Slide 28: Active Engagement in BD Opportunities
Active Engagement in BD Opportunities Goal: Non-Dilutive Resourcing and Creating Shareholder Value AEROSURF / KL4 Platform — + Exclusive global license to Lee's Pharm and Zhaoke. Potential proceeds: Global / Regional © Up to $78.9 million in potential milestone payments, low double-digit % Licensing
Slide 29: Milestones and Financial Summary
Milestones and Financial Summary Cash Sept 30, 2023 $7.4M Driving Capital Efficiency to Program Investment Significantly reduced company expenses and cash burn via out- licensing KL4 platform, focused resources on lead priority program Total Company Burn / Month Reduction YTD'22 vs. YTD'23 Non-Progr
Slide 30: Strategy for Value-Creation
Strategy for Value-Creation - Focus for the Next 4-6 Quarters Clinical Milestones Transformative BD Licensing and partnership for High IR/PR Communication WINT Team Retention, Motivation and Performance Culture 0
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