Lipella Pharmaceuticals Inc. Files 2023 10-K

TL;DR

<b>Lipella Pharmaceuticals Inc. has filed its annual 10-K report for the fiscal year ending December 31, 2023.</b>

AI Summary

LIPELLA PHARMACEUTICALS INC. (LIPO) filed a Annual Report (10-K) with the SEC on February 27, 2024. Lipella Pharmaceuticals Inc. filed its 2023 10-K on February 27, 2024. The company's fiscal year ends on December 31st. The filing covers the period from January 1, 2023, to December 31, 2023. Key financial data points for 2023 and 2022 are included. The company is incorporated in Delaware and operates in the Pharmaceutical Preparations sector.

Why It Matters

For investors and stakeholders tracking LIPELLA PHARMACEUTICALS INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Lipella Pharmaceuticals' financial performance and business operations for the fiscal year 2023, which is crucial for investors to assess the company's current standing and future prospects. The detailed financial statements and risk factors within the report offer insights into the company's revenue streams, expenses, and potential challenges, enabling stakeholders to make informed investment decisions.

Risk Assessment

Risk Level: medium — LIPELLA PHARMACEUTICALS INC. shows moderate risk based on this filing. The company operates in the pharmaceutical sector, which is subject to significant regulatory oversight, clinical trial risks, and market competition, as detailed in its 10-K filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Lipella Pharmaceuticals' financial health and strategic direction.

Revenue Breakdown

Key Numbers

• 4618965 — Grant Revenues (2023)
• 2597692 — Grant Revenues (2022)
• 10323843 — Contract Revenues (2023)
• 0 — Contract Revenues (2022)

Key Players & Entities

• LIPELLA PHARMACEUTICALS INC. (company) — Filer name
• LIPO (company) — Ticker symbol
• 2024-02-27 (date) — Filing date
• 2023-12-31 (date) — Fiscal year end
• 400 N LEXINGTON ST STE LL103, PITTSBURGH, PA 15208 (address) — Business address
• 0001347242 (company) — Central Index Key
• 2834 (industry) — Standard Industrial Classification
• DE (jurisdiction) — State of incorporation

FAQ

Key Financial Figures

• $0.0001 — h registered: Common Stock, par value $0.0001 per share LIPO Nasdaq Capital Market

Filing Documents

• g084018_10k.htm (10-K) — 1621KB
• g084018_ex14-1.htm (EX-14.1) — 55KB
• g084018_ex19-1.htm (EX-19.1) — 72KB
• g084018_ex23-1.htm (EX-23.1) — 4KB
• g084018_ex31-1.htm (EX-31.1) — 15KB
• g084018_ex31-2.htm (EX-31.2) — 15KB
• g084018_ex32-1.htm (EX-32.1) — 7KB
• g084018_ex32-2.htm (EX-32.2) — 7KB
• img001.jpg (GRAPHIC) — 35KB
• img002.jpg (GRAPHIC) — 39KB
• img003.jpg (GRAPHIC) — 25KB
• img004.jpg (GRAPHIC) — 43KB
• 0001753926-24-000403.txt (&nbsp;) — 6060KB
• lipo-20231231.xsd (EX-101.SCH) — 42KB
• lipo-20231231_cal.xml (EX-101.CAL) — 46KB
• lipo-20231231_def.xml (EX-101.DEF) — 116KB
• lipo-20231231_lab.xml (EX-101.LAB) — 327KB
• lipo-20231231_pre.xml (EX-101.PRE) — 242KB
• g084018_10k_htm.xml (XML) — 621KB

Risk Factors

Item 1A. Risk Factors 20

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 50

Cybersecurity

Item 1C. Cybersecurity 50

Properties

Item 2. Properties 50

Legal Proceedings

Item 3. Legal Proceedings 51

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 51 PART II 51

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 51

[Reserved]

Item 6. [Reserved] 52

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 52

Quantitative and Qualitative Disclosures about Market Risk

Item 7A. Quantitative and Qualitative Disclosures about Market Risk 62

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 63

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 63

Controls and Procedures

Item 9A. Controls and Procedures 63

Other Information

Item 9B. Other Information 63

Disclosure Regarding Foreign Jurisdictions That Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 63 PART III 64

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 64

Executive Compensation

Item 11. Executive Compensation 70

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 74

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 81

Principal Accountant Fees and Services

Item 14. Principal Accountant Fees and Services 82 PART IV 83

Exhibits and Financial Statement Schedules

Item 15. Exhibits and Financial Statement Schedules 83 iii pART i Item 1. Business O verview We are a clinical-stage biotechnology company that was incorporated under the laws of the State of Delaware in February 2005. We are focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. We believe that our strategy combines many of the cost efficiencies and risk abatements derived from using existing generic drugs with potential patent protections for our proprietary formulations; this strategy allows us to expedite, protect, and monetize our product candidates. Additionally, we maintain a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. We believe that this focus can potentially help reduce the cost, time and risk associated with obtaining marketing approval. We have not yet commercialized any products, and we do not expect to generate revenue from sales of any product candidates for several years. Our Lead Product Candidates: LP-10, LP-310 and LP-410 Consistent with our strategy, the initial indication that we are currently addressing (via development of our product candidate, which we have designated as LP-10) is "hemorrhagic cystitis" ("HC"), which is chronic, uncontrolled urinary blood loss that results from certain chemotherapies (such as alkylating agents) or pelvic radiation therapy (also called "radiation cystitis"). Many radiation cystitis patients experience severe morbidity (and in some cases, mortality), and currently, there is no therapy for their condition approved by the FDA, or, to our knowledge, any other regulatory body. LP-10 is the development name of our reformulation of tacrolimus (an approved generic active agent) specifically optimized for topical deposition to the internal surface of the urinary bladder lumen using a proprietary drug delivery platform t

View Full Filing

View this 10-K filing on SEC EDGAR