Windtree Therapeutics |
Company Overview |
May 2024 |
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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Multi-Asset / Indication Pipeline with Several Near-Term Milestones
Product Candidates | Indication | Phase | Development Status / Plans | |
Istaroxime | • | Positive Phase 2 study | ||
(SERCA2a activator/ | Cardiogenic Shock | Phase 2b | • | Executing small follow-on studies intended to transition to |
Na/K ATPase inhibitor) | Phase 3 | |||
• | Positive Phase 2a and 2b data | |||
• Augment AHF data with cardiogenic shock data, if positive and | ||||
Istaroxime | Acute Heart Failure | Phase 2b | adequate, for Phase 3 for AHF with partnership | |
• | Greater China regional license with Lee's Pharma who is | |||
advancing and paying for Phase 3 AHF program in territory | ||||
SERCA2a | Chronic Heart Failure, | Preclinical | • | Chronic and Acute Heart Failure |
Activators (oral) | including potentially HFpEF | • | Target for collaboration/partnership | |
aPKCi inhibitor | Cutaneous and systemic | |||
treatment in broad and/or | Preclinical | • | IND enabling studies | |
(topical and oral) | ||||
rare malignant diseases | ||||
Treatment Resistant | • | Phase 2 data in hypertension | ||
Hypertension - | ||||
Rostafuroxin | Phase 2b | • | Company holding development to out-license and reposition for | |
Genotypically identified | ||||
the attractive and large Resistant Hypertension market | ||||
patients | ||||
KL4 Surfactant and | KL4 surfactant Drug/Device | Phase 2b | • | Global out-license in place |
AEROSURF | Tx for RDS and potential | • | Partner responsible for all costs of development | |
other applications | ||||
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Milestone Strategy for Value Creation
2023 | 2024 | 2025 | ||||
Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | |
Istaroxime Cardiogenic Shock | ||||||
Phase 2 | SEISMiC B Extension Study* | Cardiogenic Shock | ||||
SEISMiC | Registration Study** | |||||
Initial Study | SCAI Stage C Study* | |||||
Reported | ||||||
Positive Results | Istaroxime in Acute Heart Failure | Acute Heart | ||||
Failure Study*** | ||||||
Oral SERCA2a Activator Heart Failure Agents; Preclinical Development | ||||||
Ista & SERCA2a Activator Deal Process | ||||||
Atypical Protein Kinase C | aPKCi; Preclinical Development | |||||
(topical and oral) | ||||||
- Study and guidance depends upon adequate funding or partnership
- Study and guidance pending positive EOP2 meeting and adequate funding
- Study and guidance pending positive EOP2 meeting and adequate funding (via partnership)
Represents planned data available | 5 |
Istaroxime
Cardiogenic Shock
Potential to transform the standard of care for critical patients
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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.
- Caused by severe impairment of cardiac function that results in diminished cardiac output, end‐organ hypoperfusion and hypoxemia
- Most often requires pharmacological or mechanical intervention with key clinical objective to increase SBP to >90mmHg and improve tissue perfusion
- Cardiogenic shock patients typically require hospital intensive care and consume significant hospital resources
- High mortality (~20-30%) and substantial morbidity in survivors1
- US + EU markets represent an ~$1.0B market potential2 with high unmet need
1) Burgos, JSCAI (1) 2021Kolte D, American Heart Association; 2014 Jan 13; (rates associated with classic, stage C shock) | 7 |
2) Estimates from claims data and epi data September 2021, multiplied by assumed various regional prices |
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 usefulness and position them as "rescue medicines"
- A therapy that can be used earlier to rapidly improve blood pressure and cardiac function without unwanted side effects is needed
Market research shows need and enthusiasm for istaroxime profile
100 U.S. Cardiologists questioned on degree of unmet need for new innovative pharmacologic treatments for ECS1
Clinical
Cardiologists
Treaters1
99
Highly Needed
Low Need
- 84% of the cardiologists responded they would be likely to extremely likely to use istaroxime for early cardiogenic shock patients
- Majority responded they would position utilization before use of other existing classes of therapies such as inotropes and vasopressors
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1) Market research conducted by Sermo, a leading provider of real time physician insights
Istaroxime - Novel First-in-Class Therapy
Novel intravenous agent designed to improve
systolic contraction anddiastolic relaxation of the heart
Increases the Force
1 of Contraction
via inhibition of the sodium-potassium pump and effects on the sodium- calcium exchanger
Dual Mechanism of
Action
2 Improves Cardiac
Relaxation
via stimulation of SERCA2a activity which enhances calcium reuptake
Impact on both systolic
(contraction) and
diastolic (relaxation)
dysfunction
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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)
- Lowered cardiac filling pressures
Increased in Systolic Blood Pressure
Increased Renal Function (eGFR)
Heart Rate Decreased
Favorable Heart Rhythm Profile Observed
- No increase in clinically significant arrythmias or ventricular tachycardia
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Windtree Therapeutics Inc. published this content on 30 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 May 2024 15:09:50 UTC.