Windtree Therapeutics, Inc. · OTC:WINT
Windtree Therapeutics — Investor Presentation (October 2024)
38 slides from Windtree Therapeutics's investor presentation, Oct 1, 2024
Slide 1: Windtree Therapeutics Investor Presentation
Windtree Therapeutics Investor Presentation October 1, 2024 Nasdaq: WINT WIND’
Slide 2: Forward-Looking Statements
Forward-Looking Statements ‘This presentation includes forward-looking statements within the meaning of Section 27A ofthe Securitas 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's
Slide 3: Windtree Investment Highlights
Windtree Investment Highlights wndece Biopharmaceutical company focused on cardiovascular and oncology treatments intended to address markets with significant unmet need (NASDAQ: WINT) First in class, novel asset istaroxime has demonstrated positive efficacy and an attractive profile in four Phase 2
Slide 4: Multi-Asset / Indication Pipeline with Several Near-Term Milestones
Multi-Asset / Indication Pipeline with Several Near-Term Milestones Product Candidates Istaroxime (SERCAZa activator NalkATPase inhibter) Istaroxime SERCA2a Activators (oral) aPKCi inhibitor (topical and oral) Rostafuroxin KL4 Surfactant and AEROSURF Indication Cardiogenic Shock Acute Heart Failure
Slide 5: Positive Istaroxime Phase Studies Demonstrated
Positive Istaroxime Phase 2 Studies Demonstrated: Cardiac Function Improved + Significant increases in cardiac output + Significant increase in stroke volume (amount of blood pumped with each heartbeat) + Lowered cardiac filling pressures Increase in Systolic Blood Pressure Increase or Preserve Rena
Slide 6: Istaroxime: Cardiogenic Shock
Istaroxime Cardiogenic Shock Potential to transform the standard of care for critical patients So
Slide 7: Cardiogenic Shock - A Critical Condition Caused by a Failing Heart
Cardiogenic Shock - A Critical Condition Caused by a Failing Heart Asevere 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: What Would the Ideal Treatment for Cardiogenic Shock Look Like?
What Would the Ideal Treatment for Cardiogenic Shock due to Heart Failure Look Like? ¥ Improves systolic and diastolic cardiac function--the root cause of cardiogenic shock v Improves blood pressure and organ perfusion--the main problem in cardiogenic shock v Avoids harming the kidneys ¥ Does not in
Slide 9: Significant Unmet Need and Reported Desire for Istaroxime
Significant Unmet Need and Reported Desire for Istaroxime No current 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 lim
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 Cy Increases the Force @ Improves Cardiac of Contraction Relaxation Via inhibition of the Via stimulation of SERCAZa sodium-potassium pump activity which e
Slide 11: SEISMIC Early Cardiogenic Shock Studies
SEISMIC Early Cardiogenic Shock Studies SEISMIC Part A SEISMIC Part B 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 istaroxime target doses were evaluated, 1.5 yg/kg/min 30 patients in early c
Slide 12: Significant Improvement on the Primary Endpoint
Significant Improvement on the Primary Endpoint SBP AUC 6 hours in SEISMIC and Part B Alone SEISMIC B
Slide 13: Significant Improvement Persisted with SBP AUC hours
Significant Improvement Persisted with SBP AUC 24 hours SEISMIC A+B SEISMIC B 0.003
Slide 14: Significant SBP Increase AUC - SEISMIC B
Significant SBP Increase AUC 48 and 60 hours - seismic B SBP AUC to 48 hours eae nena SBP AUC to 60 Hours
Slide 15: Changes in PCWP (Wedge Pressure) in SEISMIC B
Changes in PCWP (Wedge Pressure) in SEISMIC B ‘Change fom Bassin nPlraary Cepia Wedge Pressure (mtg) 0.0001
Slide 16: Significant Improvements in Cardiac Function
Significant Improvements in Cardiac Function Measured by Wedge Pressure and Cardiac Output AUCs to 48 hours in SEISMiC B Wedge Pressure Cardiac Output p-0.0017 So min ooo sma awa |
Slide 17: Changes in Heart Rate in SEISMIC B
Changes in Heart Rate to 96 hours in SEISMIC B Change fm Baseline in Heat Rate)
Slide 18: Improvements in Pulse Pressure - SEISMIC B
Improvements in Pulse Pressure to 96 hours - seismic B Post-hoc analysis ety (Change am Basel n Ps Pressure ep) © Pulse Pressure can be a surrogate for force of cardiac contraction. Diastolic blood pressure was relatively constant WINDTREE «
Slide 19: Mixed Venous Oxygen Saturation (SVO2) Significantly Improved
Mixed Venous Oxygen Saturation (SVO2), an Assessment of Organ Perfusion, was Significantly Improved by 12 Hours and Persisted _—————
Slide 20: Positive Profile in Renal Function Measured by eGFR
Positive Profile in Renal Function Measured by eGFR i SEISMIC A + SEISMIC B pts. SEISMIC B Pts. treated with <1.0 meg/kg/min (61 Pts.) ‘Chang to Baseline in Garena Faton Rat, Estates MORD (niin. 732) 6 ™ * ” % Hours frm fio nition
Slide 21: Reductions in Weight in SEISMIC B
Reductions in Weight in SEISMIC B
Slide 22: Symptoms and Signs of Congestion Improved
Symptoms and Signs of Congestion Improved with both Placebo and Istaroxime. Heart Failure Severity by NYHA Class Improved Significantly with Istaroxime Treatments 40 NYHA class ‘ . sel su 3 2 cues om i th da t ens 7 Hours from Infusion ination % P-values for win odds adjusted for baseline and, strat
Slide 23: More Istaroxime Patients Transitioned to Goal Directed Medical Therapy
More Istaroxime Patients Were Successfully Transitioned to Goal Directed Medical Therapy / Concomitant Meds at 96 hours - SEISMIC B 100.00% 90.00% 80.00% 70.00% 60.00% 50.00% 40.00% 30.00% 20.00% 10.00% 0.00% SGLT2 re 8 3 2 Fd 8 2 2 Is Fa Mistraoxime Placebo So WINDTREE Ee)
Slide 24: Adverse Events in SEISMIC B
Adverse Events in SEISMIC B Istaroxime Placebo (N=19) (N=11) All adverse events 15 (79%) 5 (46%) Thrombocytopenia 0 2 (18%) Cardiac failure 2(11%) 3 (27%) Atrial fibrillation 4 (5%) 0 Myocardial ischemia 1 (5%) 0 Ventricular extrasystoles 0 1 (9%) Ventricular tachycardia 2.(11%) 1 (9%) Infection 3(1
Slide 25: Serious Adverse Events in SEISMIC B
Serious Adverse Events in SEISMIC B Istaroxime (N=19) All serious adverse events 2 (11%) Cardiac Failure (Worsening HF) 1 (5%) Cholecystitis 0 Infection 2.(11%) Arterial hemorrhage 0 So WINDTREE 3(27%) 2 (18%) 1 (9%) 0 1 (9%)
Slide 26: Positive Trend in Composite Endpoint
Positive Trend in Composite Endpoint: SORE 08-1) Time to Worsening } Heart Failure AE, j. Heart Failure Readmission or Death through 30 days ows — SEISMIC A (1.0) +B shay O07 I 3 patients have not yet completed 30 days in SEISMIC B
Slide 27: Study Results Summary
Study Results Summary v Systolic blood pressure significantly increased with istaroxime. The increase was rapid and sustained through the infusion period v Key secondary endpoints of systolic and diastolic cardiac function such as cardiac output and filling pressures (PCWP) were significantly improv
Slide 28: Cardiogenic Shock Development Strategy
Cardiogenic Shock Development Strategy Focus on thoroughness, speed and relatively low cost of trials SEISMIC Part B Study A Extended and titrated dosing seismic W “a ales oa) Study (Part A) = Completed, positive Phase 2 Study + SCAI Stage B due to AHF SCAI Stage C sy = Gain experience in more sever
Slide 29: Professor Alexandre Mebazaa, MD, PhD, FESC
Professor Alexandre Mebazaa, MD, PhD, FESC Cardiogenic Shock Specialty: Anesthesiology and Critical Care Institute: Hépital Lariboisiére, Paris, France Functior Chairman of the Department of Anesthesia and Critical Care 7 net stans itor Pon heen il ean Ps De okt 2018-20 Dette Btn nth ely Fam Unde by
Slide 30: Cardiogenic Shock Represents a Significant Opportunity for Istaroxime and Windtree
Cardiogenic Shock Represents a Significant Opportunity for Istaroxime and Windtree vi Significant opportunity for Istaroxime to make a difference: = ~20-30% mortality in classic shock and high morbidity * Very long median length of hospital stay (~ 10 days") means high cost of hospital care (estimat
Slide 31: What Would the Ideal Treatment for Cardiogenic Shock Look Like? (Our Objective)
What Would the Ideal Treatment for Cardiogenic Shock due to Heart Failure Look Like? (Our Objective) v Improves systolic and diastolic cardiac function--the root cause of cardiogenic shock v Improves blood pressure and organ perfusion--the main problem in cardiogenic shock y Avoids harming the kidne
Slide 32: Istaroxime: Acute Heart Failure
Istaroxime Dual Mechanism SERCA2a Activator Acute Heart Failure
Slide 33: 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. hospitaliza' ~1.3M us. 7Mus, > steers id ~1.5M eu 25M F wonawide ~7% egrsiss Geo In-patient mortality annual U.S. hospital costs New pharmacologic advancements in acute 30
Slide 34: Istaroxime — Acute Heart Failure Development Strategy
Istaroxime — Acute Heart Failure Development Strategy WINDTREE 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 ion learnings from with the efficacy, safety a
Slide 35: 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 Today: Istaroxime Future: Preclinical Dual Mechanism, (SERCA2a & Na+/K+) Activators & Preclinical Pure SERCA2a Activators Dual Mechanism (SERCA2a & Na+/K+) IV only, Acute Heart Fai
Slide 36: 2024 Accomplishments, Strategy for Value Creation
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 Delivered positive data with istaroxime and the pure SERCA2a in arr
Slide 37: Financial and Deal Summary
Financial and Deal Summary ‘Completed Deals- $217MM in Potential Milestones Plus Royalties + Istaroxime, Dual-Mechanism SERCA2a Activators, June 30, 2024 $1.8M Rostafuroxin : © Exclusive Greater China regional license to Lee’s Pharm © Potential proceeds: Up to $138.1 million in potential milestone p
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