Passage BIO Files 8-K

TL;DR

Passage BIO filed a routine 8-K, no major news.

AI Summary

Passage BIO, Inc. filed an 8-K on July 16, 2024, to report on other events and financial statements. The filing does not contain specific details about new material events, significant financial changes, or executive actions beyond the standard reporting requirements.

Why It Matters

This 8-K filing indicates Passage BIO, Inc. is meeting its regulatory reporting obligations, but it does not disclose new material information that would immediately impact investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report and does not contain any new material information that would suggest an immediate change in risk.

Key Players & Entities

• Passage BIO, Inc. (company) — Registrant
• July 16, 2024 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of incorporation
• 001-39231 (filing_id) — Commission File Number
• 82-2729751 (tax_id) — IRS Employer Identification No.
• One Commerce Square (address) — Principal executive offices
• 2005 Market Street, 39th Floor (address) — Principal executive offices
• Philadelphia, PA 19103 (address) — Principal executive offices
• 267-866-0311 (phone) — Registrant's telephone number

FAQ

Key Financial Figures

• $0.0001 — nge on which registered Common Stock, $0.0001 Par Value Per Share PASG The Nasdaq

Filing Documents

• pasg-20240716x8k.htm (8-K) — 43KB
• pasg-20240716xex99d1.htm (EX-99.1) — 21KB
• pasg-20240716xex99d1001.jpg (GRAPHIC) — 6KB
• 0001558370-24-009826.txt ( ) — 201KB
• pasg-20240716.xsd (EX-101.SCH) — 3KB
• pasg-20240716_lab.xml (EX-101.LAB) — 16KB
• pasg-20240716_pre.xml (EX-101.PRE) — 10KB
• pasg-20240716x8k_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On July 16, 2024, Passage Bio, Inc. (the " Company ") issued a press release announcing positive feedback in its Type C meeting process with the U.S. Food and Drug Administration (FDA) on its proposal to evaluate PBFT02 for treating frontotemporal dementia (FTD) patients with mutations in the C9orf72 gene. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Item 7.01, including Exhibit 99.1 to this Current Report on Form 8-K, shall not be deemed to be "filed" for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act. The information contained in this Item 7.01 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

01 Other Events

Item 8.01 Other Events. PBFT02 Program Updates The Company announced the following updates with respect to PBFT02 for treating FTD patients with mutations in the C9orf72 gene following receipt of positive feedback in its Type C meeting process with the FDA. The company intends to amend the protocol for the ongoing upliFT-D Phase 1/2 global study for FTD- GRN to introduce a new population of FTD-C9orf72 patients; and The company plans to initiate dosing of FTD-C9orf72 patients in the first half of 2025.

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein that do not describe historical facts, including, but not limited to, statements regarding our expectations about timing and execution of anticipated milestones, including the initiation of dosing of FTD-C9orf72; the progress of clinical trials and the availability of clinical data from such trials; our expectations about our collaborators' and partners' ability to execute key initiatives and the ability of our lead product candidates to treat their respective target monogenic CNS disorders, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others, the risks identified in the Company's filings with the SEC, including its Quarterly Report on Form 10-Q for the three months ended March 31, 2024, filed with the SEC on May 14, 2024, and subsequent filings with the SEC. Any of these risks and uncertainties could materially and adversely affect the Company's results of operations, which would, in turn, have a significant and adverse impact on the Company's stock price. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made or to reflect the occurrence of unanticipated events.

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Passage Bio, Inc. press release dated July 16, 2024 104 Cover Page Interactive Data File (formatted as Inline XBRL). 2 3 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. PASSAGE BIO, INC. Date: July 16, 2024 By: /s/ Kathleen Borthwick Kathleen Borthwick Chief Financial Officer 4

View Full Filing

View this 8-K filing on SEC EDGAR