PolyPid Ltd. Files 20-F Annual Report for Fiscal Year Ended December 31, 2023

TL;DR

<b>PolyPid Ltd. has filed its annual 20-F report for FY2023, detailing its share structure and confirming compliance with SEC filing obligations.</b>

AI Summary

PolyPid Ltd. (PYPD) filed a Foreign Annual Report (20-F) with the SEC on March 6, 2024. PolyPid Ltd. filed its annual report on Form 20-F for the fiscal year ended December 31, 2023. The company's ordinary shares trade on the Nasdaq Capital Market under the ticker symbol PYPD. As of December 31, 2023, PolyPid Ltd. had 1,653,559 ordinary shares outstanding. The filing confirms PolyPid Ltd. is not a well-known seasoned issuer. The company has met all filing requirements for the preceding 12 months and the past 90 days.

Why It Matters

For investors and stakeholders tracking PolyPid Ltd., this filing contains several important signals. This filing provides investors with a comprehensive overview of the company's financial and operational status for the past fiscal year. The confirmation of compliance with filing requirements reassures stakeholders about the company's adherence to regulatory standards.

Risk Assessment

Risk Level: low — PolyPid Ltd. shows low risk based on this filing. The filing is a standard annual report and does not contain new material financial or operational information that would significantly alter the risk profile.

Analyst Insight

Review the full 20-F filing for detailed financial statements, risk factors, and management discussion to assess PolyPid Ltd.'s performance and outlook.

Key Numbers

• 1,653,559 — Ordinary Shares Outstanding (As of December 31, 2023)
• 2023-12-31 — Fiscal Year End (Period covered by the report)
• 2024-03-06 — Filing Date (Date the 20-F was filed)

Key Players & Entities

• PolyPid Ltd. (company) — Filer name
• PYPD (company) — Trading Symbol
• Nasdaq Capital Market (company) — Exchange where shares are registered
• December 31, 2023 (date) — Fiscal year end
• 1,653,559 (dollar_amount) — Ordinary shares outstanding as of December 31, 2023
• Dikla Czaczkes Akselbrad (person) — Chief Executive Officer of PolyPid Inc.

FAQ

Industry Context

PolyPid Ltd. operates in the biotechnology and pharmaceutical sector, focusing on the development of novel drug delivery technologies.

Regulatory Implications

The filing is a Form 20-F, which is an annual report required by the SEC for foreign private issuers.

What Investors Should Do

1. Analyze the full financial statements within the 20-F for revenue, expenses, and profitability trends.
2. Review the 'Risk Factors' section (if available in the full document) for potential challenges and uncertainties.
3. Examine any disclosures regarding executive compensation and corporate governance.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 20-F filing.
• 2024-03-06: Filing Date — Date the Form 20-F was officially submitted to the SEC.

Year-Over-Year Comparison

This is the annual report for the fiscal year ended December 31, 2023, following previous filings.

Key Financial Figures

• $10 billion — HO, estimates that SSIs result in up to $10 billion of additional hospital costs per year i

Filing Documents

• ea0200588-20f_polypidltd.htm (20-F) — 1961KB
• ea0200588ex2-4_polypid.htm (EX-2.4) — 42KB
• ea0200588ex4-15_polypid.htm (EX-4.15) — 50KB
• ea0200588ex12-1_polypid.htm (EX-12.1) — 9KB
• ea0200588ex12-2_polypid.htm (EX-12.2) — 9KB
• ea0200588ex13-1_polypid.htm (EX-13.1) — 3KB
• ea0200588ex13-2_polypid.htm (EX-13.2) — 3KB
• ea0200588ex15-1_polypid.htm (EX-15.1) — 3KB
• ea0200588ex97-1_polypid.htm (EX-97.1) — 41KB
• image_001.jpg (GRAPHIC) — 3KB
• image_002.jpg (GRAPHIC) — 61KB
• image_003.jpg (GRAPHIC) — 71KB
• image_004.jpg (GRAPHIC) — 41KB
• image_005.jpg (GRAPHIC) — 46KB
• image_006.jpg (GRAPHIC) — 52KB
• image_007.jpg (GRAPHIC) — 109KB
• image_008.jpg (GRAPHIC) — 86KB
• image_009.jpg (GRAPHIC) — 25KB
• image_010.jpg (GRAPHIC) — 25KB
• fin_001.jpg (GRAPHIC) — 3KB
• ex4-15_001.jpg (GRAPHIC) — 159KB
• 0001213900-24-020424.txt (&nbsp;) — 8817KB
• pypd-20231231.xsd (EX-101.SCH) — 70KB
• pypd-20231231_cal.xml (EX-101.CAL) — 37KB
• pypd-20231231_def.xml (EX-101.DEF) — 286KB
• pypd-20231231_lab.xml (EX-101.LAB) — 565KB
• pypd-20231231_pre.xml (EX-101.PRE) — 285KB
• ea0200588-20f_polypidltd_htm.xml (XML) — 651KB

Risk Factors

Risk Factors 1 ITEM 4. INFORMATION ON THE COMPANY 48 A. History and Development of the Company 48 B. Business Overview 48 C. Organizational Structure 84 D. Property, Plants and Equipment 84 ITEM 4.A UNRESOLVED STAFF COMMENTS 84 ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS 85 A. Operating Results 85 B. Liquidity and Capital Resources 89 C. Research and Development, Patents and Licenses, etc. 93 D. Trend Information 94 E. Critical Accounting Estimates 94 ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 97 A. Directors and Senior Management 97 B. Compensation 100 C. Board Practices 101 D. Employees 108 E. Share Ownership 108 F. Action to Recover Erroneously Awarded Compensation 108 ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 110 A. Major Shareholders 110 B. Related Party Transactions 113 C. Interests of Experts and Counsel 114 ITEM 8. FINANCIAL INFORMATION 114 A. Consolidated Statements and Other Financial Information 114 B. Significant Changes 114 ITEM 9. THE OFFER AND LISTING 114 A. Offer and Listing Details 114 B. Plan of Distribution 114 C. Markets 114 D. Selling Shareholders 114 E.

Dilution

Dilution 114 F. Expenses of the Issue 114 ITEM 10. ADDITIONAL INFORMATION 115 A. Share Capital 115 B. Memorandum and Articles of Association 115 C. Material Contracts 115 D. Exchange Controls 116 E. Taxation 116 F. Dividends and Paying Agents 123 G. 123 H. Documents on Display 123 I. Subsidiary Information 123 J. Annual Report to Security Holders 123 i Page ITEM 11.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 124 ITEM 12.

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES 124 A. Debt Securities 124 B. Warrants and rights 124 C. Other Securities 124 D. American Depositary Shares 124 PART II ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES 125 ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS O7F SECURITY HOLDERS AND USE OF PROCEEDS 125 ITEM 15.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 125 ITEM 16. [Reserved] 126 ITEM 16. A AUDIT COMMITTEE FINANCIAL EXPERT 126 ITEM 16. B CODE OF ETHICS 126 ITEM 16. C PRINCIPAL ACCOUNTANT FEES AND SERVICES 126 ITEM 16. D EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES 126 ITEM 16. E PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS 127 ITEM 16. F CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT 127 ITEM 16. G CORPORATE GOVERNANCE 127 ITEM 16. H MINE SAFETY DISCLOSURE 128 ITEM 16. I DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS. 128 ITEM 16. J INSIDER TRADING POLICIES 128 ITEM 16. K CYBERSECURITY 128 PART III ITEM 17.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 130 ITEM 18.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 130 ITEM 19. EXHIBITS 130 ii INTRODUCTION We are a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using our proprietary PLEX technology. Our product candidates are designed to address diseases with high unmet medical needs by pairing our PLEX technology with drugs already approved by the U.S. Food and Drug Administration, or FDA, or innovative drug candidates to achieve a novel therapeutic effect. Our PLEX technology is designed to deliver drugs directly to targeted treated sites in the body at predetermined release rates and predetermined durations ranging from several days to several months. We believe that our PLEX technology and product candidates have the potential to significantly improve the management of a variety of medical conditions, including surgical site infections, or SSIs, and cancer. Our lead product candidate, D-PLEX 100 , is in a pivotal Phase 3 confirmatory trial for the potential approval for prevention of SSIs in patients undergoing abdominal colorectal surgery with large incisions. D-PLEX 100 pairs our novel proprietary PLEX technology with doxycycline, a first-line, broad spectrum and FDA-approved antibiotic. D-PLEX 100 is administered directly into the surgical site during surgery, and provides a prolonged and continuous release of the broad-spectrum antibiotic, resulting in high local concentration of the drug for a period of 30 days for the prevention of SSIs, including SSIs caused by standard of care, or SoC, antibiotic-resistant bacteria. Infections resulting from surgery can be fatal and create a significant public health burden despite the extensive use of systemically administered antibiotics both pre- and post-operatively and other measures taken to reduce infection risk in the intra-operative setting. The World Health Organization, or WHO, estimates that SSIs result in up to $10 billion of additional hospital

Forward-looking statements

Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among other things: our dependence on enrollment of patients in our clinical trials in order to continue development of our product candidates; the outcomes of our anticipated interim analysis in our SHIELD II clinical trial; our ability to raise capital through the issuance of securities; our ability to advance the development of our product candidates, including the anticipated starting and ending dates of our anticipated clinical trials; our assessment of the potential of our product candidates to treat certain indications; our ability to successfully receive approvals from the FDA, EMA, or other applicable regulatory bodies, including approval to conduct clinical trials, the scope of those trials and the prospects for regulatory approval of, or other regulatory action with respect to our product candidates, including the regulatory pathway to be designated to our product candidates; the regulatory environment and changes in the health policies and regimes in the countries in which we operate, including the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; our ability to commercialize our existing product candidates and future sales of our existing product candidates or any other future potential product candidates; our ability to meet our expectations regarding the commercial supply of our product candidates; the overall global economic environm

View Full Filing

View this 20-F filing on SEC EDGAR