Passage BIO, Inc. Files 2023 Annual Report on Form 10-K

Ticker: PASG · Form: 10-K · Filed: Mar 4, 2024 · CIK: 1787297

Sentiment: neutral

Topics: 10-K, Passage BIO, Financial Report, Biotechnology, SEC Filing

TL;DR

<b>Passage BIO, Inc. has submitted its 2023 10-K filing, detailing financial performance and corporate structure.</b>

AI Summary

Passage BIO, Inc. (PASG) filed a Annual Report (10-K) with the SEC on March 4, 2024. Passage BIO, Inc. filed its 10-K report for the fiscal year ending December 31, 2023. The company is involved in the Biological Products sector, SIC code 2836. The filing includes financial data for the fiscal years 2023, 2022, and 2021. Key financial statement components such as Retained Earnings, Additional Paid-In Capital, and Accumulated Other Comprehensive Income are detailed for multiple years. Information regarding stock plans, including Employee Stock Purchase Plan and Equity Inducement Plan 2021, is provided.

Why It Matters

For investors and stakeholders tracking Passage BIO, Inc., this filing contains several important signals. This filing provides a comprehensive overview of Passage BIO's financial health and operational status for the fiscal year 2023, crucial for investors to assess the company's performance and future prospects. The detailed financial data, including equity and liability components, allows stakeholders to understand the company's capital structure and its evolution over recent years.

Risk Assessment

Risk Level: medium — Passage BIO, Inc. shows moderate risk based on this filing. The filing is a standard 10-K, which is a routine annual report. However, the absence of specific financial performance metrics like revenue or net income in the provided snippet suggests a focus on corporate structure and historical financial components rather than current operational results, which could indicate a company in early development stages or facing challenges not detailed here.

Analyst Insight

Investors should review the full 10-K filing to understand Passage BIO's financial performance, R&D pipeline, and strategic outlook.

Key Numbers

Key Players & Entities

FAQ

When did Passage BIO, Inc. file this 10-K?

Passage BIO, Inc. filed this Annual Report (10-K) with the SEC on March 4, 2024.

What is a 10-K filing?

A 10-K is a comprehensive annual financial report required by the SEC, covering audited financials, business operations, risk factors, and management discussion. This particular 10-K was filed by Passage BIO, Inc. (PASG).

Where can I read the original 10-K filing from Passage BIO, Inc.?

You can access the original filing directly on the SEC's EDGAR system. The filing is publicly available and includes all exhibits and attachments submitted by Passage BIO, Inc..

What are the key takeaways from Passage BIO, Inc.'s 10-K?

Passage BIO, Inc. filed this 10-K on March 4, 2024. Key takeaways: Passage BIO, Inc. filed its 10-K report for the fiscal year ending December 31, 2023.. The company is involved in the Biological Products sector, SIC code 2836.. The filing includes financial data for the fiscal years 2023, 2022, and 2021..

Is Passage BIO, Inc. a risky investment based on this filing?

Based on this 10-K, Passage BIO, Inc. presents a moderate-risk profile. The filing is a standard 10-K, which is a routine annual report. However, the absence of specific financial performance metrics like revenue or net income in the provided snippet suggests a focus on corporate structure and historical financial components rather than current operational results, which could indicate a company in early development stages or facing challenges not detailed here.

What should investors do after reading Passage BIO, Inc.'s 10-K?

Investors should review the full 10-K filing to understand Passage BIO's financial performance, R&D pipeline, and strategic outlook. The overall sentiment from this filing is neutral.

Key Dates

Glossary

10-K
An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (This is the primary document type filed, providing the core financial and operational data for the fiscal year.)
SIC Code
Standard Industrial Classification code used to categorize businesses based on their primary activity. (Helps identify Passage BIO's industry sector (Biological Products) for comparative analysis.)

Filing Stats: 4,481 words · 18 min read · ~15 pages · Grade level 16.6 · Accepted 2024-03-04 07:15:36

Key Financial Figures

Filing Documents

Business

Business 6 ITEM 1A.

Risk Factors

Risk Factors 38 ITEM 1B. Unresolved Staff Comments 89 ITEM 1C. Cybersecurity 90 ITEM 2.

Properties

Properties 92 ITEM 3.

Legal Proceedings

Legal Proceedings 93 ITEM 4. Mine Safety Disclosures 93 PART II 94 ITEM 5. Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities 94 ITEM 6. [Reserved] 94 ITEM 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 95 ITEM 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 105 ITEM 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 106 ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 132 ITEM 9A.

Controls and Procedures

Controls and Procedures 132 ITEM 9B. Other Information 133 ITEM 9C . Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 133 PART III 134 ITEM 10. Directors, Executive Officers, and Corporate Governance 134 ITEM 11.

Executive Compensation

Executive Compensation 135 ITEM 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 136 ITEM 13. Certain Relationships and Related Transactions, and Director Independence 137 ITEM 14. Principal Accountant Fees and Services 138 PART IV 139 ITEM 15. Exhibits and Financial Statement Schedules 139 ITEM 16. Form 10-K Summary 144

Signatures

Signatures 145 2 Table of Contents CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements. All statements other than statements of historical facts contained in this Annual Report are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "aim," "may," "will," "should," "expect," "forecast," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. All statements other than statements of historical fact contained in this Annual Report, including without limitation statements regarding our plans to develop and commercialize our product candidates, the timing and results of our ongoing or planned preclinical studies and clinical trials, risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, the timing of and our ability to obtain and maintain regulatory approvals, the clinical utility of our product candidates, our commercialization, marketing and manufacturing capabilities and strategy, our expectations about the willingness of healthcare professionals to use our product candidates, the sufficiency of our cash and cash equivalents, general economic, industry and market conditions, including interest rates and inflation, and instability in the global banking system, our activities to evaluate and pursue potential out-licensing opportunities following our determination to discontinue the advancement of certain product candidates, and the plans and objectives of management for future operations and capital expenditures are forward-looking statements. The forward-looking statements in this Annual Report

Business

Item 1. Business Overview We are a clinical stage genetic medicines company on a mission to improve the lives of patients with neurodegenerative diseases. Our primary focus is the development and advancement of cutting-edge, one-time gene therapies designed to target the underlying pathology of these conditions. We believe we have developed a differentiated approach to developing treatments for central nervous system, or CNS, disorders that allows us to select and advance product candidates with a higher probability of technical and regulatory success. Our lead clinical product candidate, PBFT02, seeks to elevate progranulin levels to restore lysosomal function and slow disease progression across a variety of neurodegenerative diseases. PBFT02 utilizes an adeno-associated virus, or AAV1, capsid to deliver a functional granulin gene, or GRN , encoding progranulin, or PGRN, to the brain via intra cisterna magna, or ICM, administration . The lead indication for PBFT02 is frontotemporal dementia, or FTD, caused by progranulin deficiency, or FTD- GRN . We believe this clinical product candidate has the potential to provide patients with significantly improved outcomes given the rigorous capsid and transgene selection process, and our chosen route of ICM administration, which provides the potential for enhanced benefits due to widespread vector delivery to the brain and spinal cord and an improved safety profile compared with systemic administration due to the lower doses required. We are currently studying PBFT02 in FTD- GRN , for which there are currently no approved disease-modifying therapies. In addition to the continued clinical development of PBFT02 to treat FTD- GRN , we intend to pursue PBFT02 in additional adult neurodegenerative diseases where we believe increasing PGRN levels could provide benefit. Third-party preclinical studies have shown that increased PGRN levels reduce the pathologic accumulation of TAR DNA binding protein 43, or TDP-43. TDP-43 pa

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