Passage BIO, Inc. Files 8-K Report

Ticker: PASG · Form: 8-K · Filed: Sep 16, 2024 · CIK: 1787297

Sentiment: neutral

Topics: 8-K, SEC Filing, Disclosure

TL;DR

Passage BIO filed an 8-K, likely with updates. Keep an eye out for details.

AI Summary

On September 16, 2024, Passage BIO, Inc. filed an 8-K report. The filing primarily concerns Regulation FD disclosures and other events, including financial statements and exhibits. No specific material events or financial figures were detailed in the provided excerpt.

Why It Matters

This filing indicates Passage BIO, Inc. is providing updates or disclosures to the SEC, which could contain material information for investors.

Risk Assessment

Risk Level: low — The provided excerpt is a standard 8-K filing notification and does not contain specific material events or financial data that would indicate a high risk.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing for Passage BIO, Inc.?

The filing is for Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits, as of September 16, 2024.

What is Passage BIO, Inc.'s Central Index Key (CIK)?

Passage BIO, Inc.'s CIK is 0001787297.

When was Passage BIO, Inc. incorporated?

Passage BIO, Inc. was incorporated in Delaware.

What is the business address of Passage BIO, Inc.?

The business address is One Commerce Square, 2005 Market Street, 39th Floor, Philadelphia, PA 19103.

What is the fiscal year end for Passage BIO, Inc.?

The fiscal year end for Passage BIO, Inc. is December 31st.

Filing Stats: 808 words · 3 min read · ~3 pages · Grade level 9.3 · Accepted 2024-09-16 07:00:19

Key Financial Figures

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On September 16, 2024, Passage Bio Inc. (the "Company" ) issued a press release and updated its corporate presentation related to its poster presentation at the 14 th International Conference on Frontotemporal Dementias (the "ISFTD2024 Poster" ). A copy of the press release, corporate presentation, and ISFTD2024 Poster are attached as Exhibits 99.1, 99.2 and 99.3, respectively, to this Current Report on Form 8-K. The information in this Item 7.01, including Exhibits 99.1, 99.2 and 99.3 to this Current Report on Form 8-K, shall not be deemed to be "filed" for purposes of Section 18 of the Exchange Act of 1934, as amended (the " Exchange Act "), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the " Securities Act ") The information contained in this Item 7.01 and in the accompanying Exhibits 99.1, 99.2 and 99.3 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 On September 16, 2024, the Company announced updated interim safety and biomarker data from Cohort 1 patients who received Dose 1 of PBFT02 from the Company's ongoing global Phase 1/2 clinical trial, upliFT-D, evaluating PBFT02, an adeno-associated virus-delivery gene therapy for the treatment of patients aged 35 to 75 years with frontotemporal dementia caused by progranulin deficiency, or FTD- GRN . PBFT02 was well-tolerated in all patients (patients 2, 3, 4 and 5) who received an enhanced immunosuppression regimen following protocol amendment, as of August 20, 2024. PBFT02 resulted in increased progranulin ( "PGRN" ) levels in the cerebral spinal fluid ( " CSF " ) in all patients , relative to baseline, with up to a 6-fold increase at one month (range of 10.7 to 17.3 ng/mL; n=5) and up to a 10-fold increase at six months (range of 21.7 to 27.3 ng/mL; n=2). The effect of PBFT02 was consistent across all patients, with CSF PGRN levels exceeding the range found in healthy adult controls of 3.3 to 8.2 ng/mL (n=61). CSF PGRN remained elevated at 12 months (n=1), reaching a level of 34.2 ng/mL. The rate of increase was 58% between one month and six months and slowed to 26% between six months and twelve months. Plasma PGRN expression remained below healthy reference levels across all patients.

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 September 16, 2024 99.2 Corporate Presentation 99.3 ISFTD2024 Poster 104 Cover Page Interactive Data File (formatted as Inline XBRL). 2 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: September 16, 2024 By: /s/ Kathleen Borthwick Kathleen Borthwick Chief Financial Officer 3

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