Item 2.02 Results of operations and financial position

At January 10, 2022, Passage Bio, Inc. (the “Company”) will present a corporate presentation (the “JPM Presentation”) at the 40th Annual JP Morgan Healthcare Conference (“JPM”), which will report the preliminary unaudited amount of cash, cash equivalents and the Company’s marketable securities position. from
December 31, 2021, like about $ 316 million, which the Company believes will allow it to fund its operating and capital expenditures until the end of fiscal 2023. This amount is preliminary, unaudited and subject to change, has been prepared by management and is based on the most recent information available to it, and is subject to management’s completion of the financial statements from and for the year ended December 31, 2021, including the completion of review procedures, final adjustments and other developments that may arise between now and the finalization of the financial results for that period, and the completion of the audit of these financial statements.

Article 7.01 Regulation FD Disclosure.

In addition to the company’s presentation of the JPM presentation, the company also issued a press release regarding updates to the company’s clinical programs, pipeline programs in the research phase and manufacturing plans on January 10, 2022.

A copy of the press release and the JPM presentation is attached as Exhibits 99.1 and 99.2, respectively, to this current report on Form 8-K.

The information in this Section 7.01, including Exhibits 99.1 and 99.2 of this report, will not be deemed to be “filed” for the purposes of Section 18 of the Exchange Act, or otherwise subject to the obligations of this section or of the Articles 11 and 12 (a) (2) of the Securities Act. The information in this Section 7.01 and in Attachments 99.1 and 99.2 should not be incorporated by reference in any other filing under the Exchange Act or the Securities Act, except as expressly indicated by specific reference in a such deposit.

Item 8.01 Other Events.

The information set out in section 2.02 above is incorporated by reference into this section 8.01.

Clinical and research stage pipeline programs

The Company announced the following updates regarding its clinical and research pipeline programs:

? In his Imagine-1 clinical trial, he expects to assay the first patients in

cohorts 2 and 3 at the start of 2022.

? The target of its previously undisclosed program in the treatment of the central nervous system in adults

System disorders is PRKN for Parkinson’s disease.

For its metachromatic leukodystrophy (“MLD”) program (PBML04), the Company

the current approach is to use the intra cisterna magna (“ICM”) route of administration

and an AAVhu68 capsid to deliver a functional ARSA gene. Preclinical data

? showed that PBML04 delivered by intracerebroventricular (“ICV”) administration

dose-dependent reduced functional decline and increased survival in a novel

MLD mouse model. Company plans to submit new investigational drug

application for the Phase 1/2 clinical program for MLD in mid-year 2022.

For its Charcot-Marie-Tooth Type 2A (“CMT2A”) program (PBCM06), the

the current approach is to use the ICM route of administration and the AAV administration of a

? combination of miRNA and genes to eliminate the mutant and replace it with the functional one

NPF2. Preclinical pilot data identified a probe construct that improves the distal portion

limb weakness (grip strength) after administration of ICV in mice with a mutation in the

   MFN2 gene.

For its amyotrophic lateral sclerosis (“ALS”) program (PBAL05), the

the current approach is to use the ICM route of administration and the AAV administration of a

? combination of miRNA and genes to eliminate the mutant and replace it with the functional one

C9orf72. Preclinical pilot data showed that AAV-C9miRNA normalized

levels of toxic poly (GP) dipeptide repeated proteins in the brain of mice with a mutation

   in the C9-ALS gene.


                                       2

Manufacturing

The company plans to operationalize a new pilot manufacturing suite by the end of 2022 at the Princeton West Innovation Campus in Hopewell, New Jersey, for its ability to scale to support its research and development pipeline as well as its future development plans.

Item 9.01 Financial statements and supporting documents.

(d) Exhibits



Exhibit No.                            Description

99.1             Passage Bio, Inc. press release dated January 10, 2022.
99.2             Corporate Presentation.
104            Cover Page Interactive Data File (formatted as Inline XBRL).








                                       3

© Edgar online, source Previews