Windtree Therapeutics Files 2023 Annual Report on Form 10-K

TL;DR

<b>Windtree Therapeutics Inc. filed its 2023 10-K, detailing its financial position with $5.99M in assets and $0.77M in debt as of year-end.</b>

AI Summary

WINDTREE THERAPEUTICS INC /DE/ (WINTW) filed a Annual Report (10-K) with the SEC on April 16, 2024. Windtree Therapeutics reported total assets of $5,996,587 as of December 31, 2023. The company had total debt of $772,203 as of December 31, 2023. Revenue for the fiscal year ending December 31, 2023, was not explicitly stated but implied by growth figures. Net income for the fiscal year ending December 31, 2023, was not explicitly stated. The company's fiscal year ends on December 31.

Why It Matters

For investors and stakeholders tracking WINDTREE THERAPEUTICS INC /DE/, this filing contains several important signals. This filing provides a comprehensive overview of Windtree Therapeutics' financial health and operational status for the fiscal year 2023, crucial for investors assessing its current standing and future prospects. The report includes detailed financial statements, risk factors, and business descriptions, offering insights into the company's strategic direction and potential challenges in the biotechnology sector.

Risk Assessment

Risk Level: medium — WINDTREE THERAPEUTICS INC /DE/ shows moderate risk based on this filing. The company's financial disclosures in this 10-K indicate a need for further capital, as evidenced by the significant cash burn implied by the limited revenue and ongoing operational expenses, typical for a clinical-stage biotechnology company.

Analyst Insight

Investors should review the "Risk Factors" section of the 10-K to understand the specific challenges Windtree Therapeutics faces, particularly concerning its ability to secure future funding and advance its product pipeline.

Financial Highlights

total Assets

5996587

total Debt

772203

Key Numbers

• 5,996,587 — Total Assets (As of December 31, 2023)
• 772,203 — Total Debt (As of December 31, 2023)
• 1231 — Fiscal Year End (Annual reporting period)
• 2023-12-31 — Fiscal Year End Date (Reporting period)
• 2022-12-31 — Previous Fiscal Year End Date (Comparative period)
• 2.9 — Growth Rate (Implied revenue growth percentage)
• 6.8 — Growth Rate (Implied net income growth percentage)
• 0.001 — Share Price (Per share value)

Key Players & Entities

• WINDTREE THERAPEUTICS INC /DE/ (company) — Filer name
• 20231231 (date) — Conformed period of report
• 20240416 (date) — Filed as of date
• 0000946486 (company) — Central Index Key
• DE (jurisdiction) — State of incorporation
• PA (jurisdiction) — State of business address
• DISCOVERY LABORATORIES INC /DE/ (company) — Former company name
• Battelle (company) — Collaboration agreement

FAQ

Risk Factors

• Ability to Continue as a Going Concern [high — financial]: The company's recurring losses and cash flow deficits raise substantial doubt about its ability to continue as a going concern without additional financing.
• Regulatory Approval Process [medium — regulatory]: The development and commercialization of the company's products are subject to extensive regulatory review and approval processes by agencies like the FDA, which can be lengthy and uncertain.
• Competition [medium — market]: The biotechnology market is highly competitive, with numerous companies developing similar therapies, posing a risk to market penetration and profitability.
• Reliance on Key Personnel [medium — operational]: The company's success depends significantly on its ability to attract and retain qualified scientific and management personnel.
• Financing Requirements [high — financial]: The company will require substantial additional capital to fund its ongoing research, development, and potential commercialization activities.

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value WINT The Nasdaq Capital M

Filing Documents

• wint20231231_10k.htm (10-K) — 2774KB
• ex_653402.htm (EX-3.1) — 343KB
• ex_653403.htm (EX-4.18) — 17KB
• ex_653611.htm (EX-10.3) — 38KB
• ex_652996.htm (EX-10.5) — 46KB
• ex_652997.htm (EX-10.61) — 543KB
• ex_653612.htm (EX-23.1) — 11KB
• ex_598669.htm (EX-31.1) — 14KB
• ex_598671.htm (EX-32.1) — 7KB
• ex_653404.htm (EX-97.1) — 32KB
• 0001437749-24-012210.txt (&nbsp;) — 10864KB
• wint-20231231.xsd (EX-101.SCH) — 81KB
• wint-20231231_cal.xml (EX-101.CAL) — 50KB
• wint-20231231_def.xml (EX-101.DEF) — 562KB
• wint-20231231_lab.xml (EX-101.LAB) — 470KB
• wint-20231231_pre.xml (EX-101.PRE) — 587KB
• wint20231231_10k_htm.xml (XML) — 1264KB

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains " forward-looking statements " within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These 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. Forward-looking statements are subject to many risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. We caution you therefore against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. Examples of such risks and uncertainties, which potentially could have a material adverse effect on our development programs, business and/or operations, include, but are not limited to the following: our estimates regarding future results of operations, financial position, research and development costs, capital requirements, and our needs for additional financing; how long we can continue to fund our operations with our existing cash and cash equivalents; our ability to meet and regain compliance with the listing requirements of the Nasdaq Stock Market L

BUSINESS

ITEM 1. BUSINESS. 1

RISK FACTORS

ITEM 1A. RISK FACTORS. 29

UNRESOLVED STAFF COMMENTS

ITEM 1B. UNRESOLVED STAFF COMMENTS. 65

CYBERSECURITY

ITEM 1C. CYBERSECURITY. 66

PROPERTIES

ITEM 2. PROPERTIES. 66

LEGAL PROCEEDINGS

ITEM 3. LEGAL PROCEEDINGS. 66

MINE SAFETY DISCLOSURES

ITEM 4. MINE SAFETY DISCLOSURES 66 PART II 67

MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. 67

[Reserved]

ITEM 6. [Reserved]. 67

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. 67

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. 78

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. 78

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. 78

CONTROLS AND PROCEDURES

ITEM 9A. CONTROLS AND PROCEDURES. 79

OTHER INFORMATION

ITEM 9B. OTHER INFORMATION. 79

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS. 79 PART III 80

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 80

EXECUTIVE COMPENSATION

ITEM 11. EXECUTIVE COMPENSATION 84

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 91

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 93

PRINCIPAL ACCOUNTANT FEES AND SERVICES

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 95 PART IV 96

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES. 96

SIGNATURES

SIGNATURES 102 Table of Contents PART I

BUSINESS

ITEM 1. BUSINESS. Overview We are a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Our portfolio of product candidates includes istaroxime, a Phase 2 candidate with sarco endoplasmic reticulum Ca2+ -ATPase 2a, or SERCA2a, activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure, rostafuroxin for the treatment of hypertension in patients with a specific genetic profile, and a preclinical atypical protein kinase C iota, or aPKCi, inhibitor (topical and oral formulations), being developed for potential application in rare and broad oncology indications. We also have a licensing business model with partnership out-licenses currently in place. Our lead product candidate, istaroxime, is a first-in-class, dual-acting agent being developed to increase blood pressure and improve cardiac function in patients with cardiogenic shock and to improve cardiac function in patients with acute heart failure, or AHF, and reverse the hypotension and hypoperfusion associated with heart failure that deteriorates to cardiogenic shock. Istaroxime demonstrated significant improvement in both systolic and diastolic aspects of cardiac function and was generally well tolerated in three Phase 2 clinical trials. Istaroxime has been granted Fast Track designation for the treatment of AHF by the U.S. Food and Drug Administration, or FDA. Based on the profile observed in our Phase 2 clinical studies in AHF, where istaroxime significantly improved cardiac function and systolic blood pressure, or SBP, in acute decompensated heart failure patients and had a favorable renal profile, we initiated a Phase 2 global clinical study, or the SEISMiC Study, to evaluate istaroxime for the treatment of early cardiogenic shock (Society for Cardiovascular Angiography and Interventions, or SCAI, Stage B shock), a severe form of AHF characterized by very low blood p

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