Windtree Therapeutics, Inc. · OTC:WINT
Windtree Therapeutics — Investor Presentation (September 2024)
32 slides from Windtree Therapeutics's investor presentation, Sep 13, 2024
Slide 1: Windtree Therapeutics Corporate Overview
Windtree Therapeutics Corporate Overview September 2024 Nasdaq: WINT WINDTREE
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 Section21E ofthe Securities Exchange Act of 1934, as amended. These statements, among other things, include statements about the Company's c
Slide 3: Windtree Investment Highlights
Windtree Investment Highlights wit brce Biopharmaceutical company focused on cardiovascular and oncology treatments intended to address markets with significant unmet need (NASDAQ: WINT) V Firstin class, novel asset istaroxime has demonstrated positive efficacy and an attractive profile in three Pha
Slide 4: Multi-Asset / Indication Pipeline with Several Near-Term Milestones
Multi-Asset / Indication Pipeline with Several Near-Term Milestones ProductCandidates _| indication Istaroxime (SERCAZaacivatod’ _ Cardiogenic Shock Naik ATPase inher) Istaroxime Acute Heart Failure SERCA2a Chronic Heart Failure, Activators (oral) including potentially HFpEF j inhibitor Cutaneousand
Slide 5: Windtree Strategy for Value Creation — Deliver Data and Deals
Windtree Strategy for Value Creation — Deliver Data and Deals 4H 2024 Accomplishments FPI global Phase 2b Extension Study of istaroxime in Cardiogenic Shock ‘$138MM plus royalties regional license secured for CV products Eliminated $15MM in liabilities with Deerfield, added to shareholder equity Del
Slide 6: Milestone Strategy for Value Creation
Milestone Strategy for Value Creation 2023 2024 2025 Q3 Q4 Qi Q2 Q3 Q4 @ Istaroxime Cardiogenic Shock vent EES © Baie, a © a Istaroxime in Acute Heart Failure S WINDTREE
Slide 7: Istaroxime Cardiogenic Shock
Istaroxime Cardiogenic Shock Potential to transform the standard of care for critical patients S winoTREE
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 their
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 Increases the Force of Contraction a inhibition of the Sodium-potassium pump ‘and effects on the sodium: calcium exchanger @ impro
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 60 patients in early cardiogenic shock (SBP 75-90 mmHg) with AHF Study drug was infused for 24 hours in a 1:1 randomization to placebo or istaroxime. Two
Slide 13: Istaroxime Achieved Positive Primary Endpoint
2020102 Istaroxime Achieved Positive Primary Endpoint Systolic Blood Pressure AUC through 6 Hours - mI TT Population ai Bistaroxine Zh ‘BPlacebo En zu Bio ae e5 as Bs 84 2028 3 445 8 8S 8g Hours from Infusion Inittation td { winoTREE »|
Slide 14: Systolic BP Improvements Persisted over Hours
Systolic BP Improvements Persisted over 24 Hours Systolic Blood Pressure ‘mITT Population ‘Change n SBP (mmHg) P=0.025 for AUC Hours from infusion initiation oe WINDTREE 24
Slide 15: Cardiac Function Improvement
Cardiac Function Improvement Echocardiography demonstrated improvements in key systolic and diastolic cardiac function measures including: ¥ 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) subs
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 . —___________ Estimated Glomerular Filtration Rate —e Isaoxme 4) =e Praceto 2 WINDTREE
Slide 17: 1.0 ug/kg/min Produced a Favorable Effect on SBP
1.0 pg/kg/min Produced a Favorable Effect on SBP 1.0 ug/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 profile uy | 210 poem 215 yoko min
Slide 18: SEISMIC Study Results Summary
SEISMIC Study Results Summary 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 pos
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 SEISMiC wr Soon Phase 3* Study + Execute £OP2 meeting ith these 3 studies = Completed, positive Expected Steps to Phase 3 Reat bss Repel augmen
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 v SBP significantly increased versus control with a profile of rapid correction that is sustained through the 96-hour post-infusion measure ¥ 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 VY. 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 (est
Slide 22: Istaroxime Acute Heart Failure
Istaroxime Dual Mechanism SERCA2a Activator Acute Heart Failure 3 WINDTREE
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 Annual Admissions Patients #1 cause of U.S. hospitalization ~1.3M us. in patients ~ > 65 years old 1.5M ev ~T% ff >$18B Oo In-patient mortality annual U.S. hospital costs New pharmacologic , , advancements in acute
Slide 24: Istaroxime AHF Phase 2a & 2b Studies
Istaroxime AHF Phase 2a & 2b Studies Phase 2a n=120 Dosing= 6 hour ADHE Patients 0.5, 1.0, 1.5 yokomin Infusion Phase n=120 Dosing= 24 hour ADHE Patients 0.5, 1.0 vokomn Infusion 2b (ayspneapusnees tor Rrosemae > mg) ‘+ Primary: PCWP significantly improved + Stroke Vol & SBP — significantiincrease +
Slide 25: Next Steps
Next Steps 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 with the efficacy, safety and dosing and ch
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 Istaroxime Future: Preclinical Dual Mechanism, (SERCA2a & Na+/K+) Activators. & Preclinical Pure SERCA2a Activators Dual Mechanis sm (SERCA2a & Na#/K+) IV only, Acute Heart Failure
Slide 27: Atypical Protein Kinase C iota (aPKCi) Inhibitors
Atypical Protein Kinase C iota (aPKCi) Inhibitors Potential Multiple Tumor Types Innovative topical and oral formulations S winoTREE
Slide 28: Oncology Assets: aPKCi Topical (VAR-101) and Oral (VAR-102)
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 treatment of
Slide 29: Oncology Assets: aPKCi inhibitor Topical and Oral Next Steps
Oncology Assets: aPKCi inhibitor Topical and Oral Next Steps ¥ Progress the IND-enabling activities including pre-IND meeting, toxicology (including topical) Y Createa comprehensive clinical and CMC development plan that leverages the assets’ unique characteristics and mechanisms of action on the hi
Slide 30: Matching Preclinical Data, Attributes, Scientific Rationale and Market Opportunities
Matching Preclinical Data, Attributes, Scien ic Rationale and Market Opportunities for Optimal Development Path Early Observations of the Key Attributes of Active Pharmaceutical Agent al Y Molecules designed through med chem, SAR, Design andin vitroandin vivotesting “cog inane vc ERIC ccm, ” Thereis
Slide 31: Financial and Deal Summary
Financial and Deal Summary Cash June 30, 2024 $1.8M Common Stock Outstanding September 13, 2024 1,610,734 Driving Capital Efficiency to Program Investment In 2023, significantly reduced company expenses and cash burn (28%) via outdicensing KL4 platform, focusing resources on istaroxime lead priority
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