Windtree Therapeutics, Inc. · OTC:WINT
Windtree Therapeutics — Investor Presentation (July 2024)
32 slides from Windtree Therapeutics's investor presentation, Jul 3, 2024
Slide 1: Windtree Therapeutics Investor Presentation
Windtree Therapeutics Investor Presentation July 2024 Nasdaq: WINT WINDTREE THERAPEUTICS
Slide 2: Forward-Looking Statements
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 ofthe Securities Exchange Act of 1934, as amended. These statements, among other things, include statements about the Company'
Slide 3: Windtree Investment Highlights
Windtree Investment Highlights wn bace \V¥ Biopharmaceutical company focused on cardiovascular and oncology treatments intended to address ~~ markets with significant unmet need (NASDAQ: WINT) ‘V First in class, novel asset istaroxime has demonstrated positive efficacy and an attractive profile in t
Slide 4: Multi-Asset / Indication Pipeline with Several Near-Term Milestones
Multi-Asset / Indication Pipeline with Several Near-Term Milestones oduct Candidates jingication =| Phase | Development Status / Plans Istaroxime (SERCA2a activator! Na/K ATPase inhibitor) Istaroxime SERCA2a Activators (oral) aPKCi inhibitor (topical and oral) Rostafuroxin KL4 Surfactant and AEROSUR
Slide 5: Windtree Strategy for Value Creation — Deliver Data and Deals
Windtree Strategy for Value Creation — Deliver Data and Deals 1H 2024 Accomplishments v FPI global Phase 2b Extension Study of istaroxime in Cardiogenic Shock ¥ $138MM plus royalties’ regional license secured for CV products v Eliminated $15M™M in liabilities with Deerfield, added to shareholder equ
Slide 6: Milestone Strategy for Value Creation
Milestone Strategy for Value Creation Q3 Q4 Qi Q2 Q3 Q4 O Istaroxime Cardiogenic Shock Phase2 SEISMIC Initial Study Reported Positive Results Istaroxime in Acute Heart F. aa en foes oa c aPKCi; Preclinical Development ge *_ Study and guidance depends upon adequate funding or partnership 26 * Study a
Slide 7: Istaroxime Cardiogenic Shock
Istaroxime Cardiogenic Shock Potential to transform the standard of care for critical patients @ WINDTREE \7
Slide 8: 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 9: Significant Unmet Need and Reported Desire for Istaroxime
Significant Unmet Need and Reported Desire for Istaroxime * No satisfactory pharmacological intervention to reverse the condition — Available therapies have unwanted side effects such as risk for arrhythmias, decreasing blood pressure, renal dysfunction and even increases in mortality that limit the
Slide 10: Istaroxime — Novel First-in-Class Therapy
Istaroxime — Novel First-in-Class Therapy Novel intravenous agent designed to improve systolic contraction and diastolic relaxation of the heart Dual Mechanism of Action 2 Improves Cardiac Relaxation via stimulation of SERCA2a activity which enhances calcium reuptake @ Increases the Force of Contrac
Slide 11: 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 In Phase 2a and 2b data in AHF istaroxime demonstrated: Cardiac Function Improved with Both Doses + Significant increase in stroke volume (amount of blood expelled with each heartbeat) +
Slide 12: 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 E70) 60 patients in early cardiogenic shock (SBP 75-90 mmHg) with AHF Study drug was infused for 24 hours ina 1:1 randomization to placebo or istaroxime.
Slide 13: Primary Endpoint
\ Primary Endpoint Endpoint Istaroxime Achieved Positive Primary Endpoint Systolic Blood Pressure AUC through 6 Hours - mITT Population EG Gistaroxime Placebo i a fal a 89 BS 97 Bo gs S a4 & 3 § 2 Oo} 0 0 os 1 is 2 25 3 35 4 45 5 S55 6 bys Hours from Infusion Inititation WINDTREE
Slide 14: Secondary Results
\ Secondary Results Results Systolic BP Improvements Persisted over 24 Hours Systolic Blood Pressure mITT Population 18 —®— Istaroxime a ®- Placebo ? 6 3 E14 a a < 12 S 2 10 5 = 9° 8 6 : ! } } p=0.025 for AUC 2 0 0 12 24 Hours from Infusion Initiation fale w6@ — WINDTREE [14
Slide 15: Cardiac Function Improvement
Cardiac Function Improvement Echocardiography demonstrated improvements in key systolic and diastolic cardiac function measures including: y¥ Cardiac index (amount of output from the heart over a minute) significantly increased v Stroke volume (amount of blood from the heart with each heartbeat) sub
Slide 16: 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 cgg¢§ Estimated Glomerular Filtration Rate - mITT Population z z £ E z 6 = ° £ 3 2 3 & a & - -* £ Tis => 3 Ss oe & - § —e- Istaroxime a 6 co © Placebo 8 oO 12 24 36 48 60 72 84 96
Slide 17: Comparison of Doses
\ Comparison of Doses of Doses 1.0 pg/kg/min Produced a Favorable Effect on SBP 1.0 pg/kg/min 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 pro
Slide 18: 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 19: 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 of SERCAZa effect presse Study = Execute EOP2 meeting = Completed, positive Expected S
Slide 20: SEISMiC Extension Study Desired Results
SEISMiC Extension Study Desired Results: Good Efficacy and Safety Data Support an Optimized Dose for Phase 3 Planning ¥ SBP significantly increased versus control with a profile of rapid correction that is sustained through the 96-hour post-infusion measure v Secondary endpoints of cardiac function
Slide 21: Cardiogenic Shock Represents a Significant Opportunity for Istaroxime and Windtree
Cardiogenic Shock Represents a Significant Opportunity for Istaroxime and Windtree A Significant opportunity for Istaroxime to make a difference: = ~20-30% mortality in classic shock and high morbidity = Very long average length of hospital stay (~ 19.5 days) means high cost of hospital care (estima
Slide 22: Istaroxime Acute Heart Failure
Istaroxime Dual Mechanism SERCA2a Activator Acute Heart “~. Failure
Slide 23: 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 #1 cause of U.S. Annual Admissions hospitalization ~1.3M us. TMs. i PEeenes ~1.5M ev. 25M F wordwiae > 65 years old — ~7T% ey >$18B © 0) In-patient mortality annual U.S. hospital costs New pharmacologic advancements
Slide 24: Istaroxime AHF Phase 2a & 2b Studies
Istaroxime AHF Phase 2a & 2b Studies & h © Phase 2a n=120 Dosing= 6 hour ADHF Patients 0.5, 1, 1.5 ugikaimin Infusion Phase n=120 Dosing= 24 hour 2b ADHF Patients 9.5, 1.0 ugikgimin Infusion (dyspnea plus need for lV furosemide > 40mg) * Primary: PCWP significantly improved * Stroke Vol & SBP — sign
Slide 25: Istaroxime — Acute Heart Failure Development Strategy
| Istaroxime — Acute Heart Failure Development Strategy Regional Strategy: Licensing Partner in Asia / Pac Intends to Start Phase 3 AHF Study Global Phase 3 AHF Program Strategy Augment our data from the positive phase 2a and phase 2b AHF studies Ld with the efficacy, safety and dosing and character
Slide 26: Next Generation, Oral SERCA2a Activators Platform
Next Generation, Oral SERCA2a Activators Platform has Potential for both Major Types of HF in Acute and Chronic Therapy Development Strategy: Today: - AHF + Dual Mechanism (SERCA2a & Na+/K+) Hospital, Istaroxime * IV only, Acute Heart Failure with Reduced Ejection a Fraction (HFrEF) with normal / lo
Slide 27: Atypical Protein Kinase C iota (aPKCi) Inhibitors
wy % Atypical Protein Kinase C iota (aPKCi) Inhibitors Potential Multiple Tumor Types Innovative topical and oral formulations WINDTREE
Slide 28: Oncology Assets: aPKCi Topical (VAR-101) and Oral (VAR-102)
WINDTREE Oncology Assets: aPKCi Topical (VAR-101) and Oral (VAR-102) Newly acquired, first in class atypical protein kinase C iota inhibitors (aPKCi) v Novel, emerging oncogenic target + Protein kinase inhibitors are a class of anti-cancer therapeutics that have made a significant impact on the trea
Slide 29: Oncology Assets: aPKCi inhibitor Topical and Oral Next Steps
Oncology Assets: aPKCi inhibitor Topical and Oral Next Steps v Progress the IND-enabling activities including pre-IND meeting, toxicology (including topical) v Create a comprehensive clinical and CMC development plan that leverages the assets’ unique characteristics and mechanisms of action on the h
Slide 30: Matching Preclinical Data, Attributes, Scientific Rationale and Market Opportunities
Matching Preclinical Data, Attributes, Scientific Rationale and Market Opportunities for Optimal Development Path Early Observations of the Key Attributes of Active Pharmaceutical Agent Ra E| v Molecules designed through med chem, SAR, Design andin vitro andin vivotesting ~ High degree of kinome sel
Slide 31: Financial and Deal Summary
Financial and Deal Summary Cash Completed Deals- $217MM in March 31, 2024 $2.5M Potential Milestones Plus Royalties + Istaroxime, Dual-Mechanism SERCAZ2a Activators, Rosta o Exclusive Greater China regional license to Lee’s Pharm o Potential proceeds: Up to $138.1 million in potential June 30, 2024
Slide 32: Windtree Therapeutics
WINDTREE % THERAPEUTICS:
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