Item 2.02 Results of Operations and Financial Condition
On
Item 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, research-stage pipeline programs, and manufacturing plans on
A copy of the press release and JPM Presentation are attached as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K.
The information in this Item 7.01, including Exhibits 99.1 and 99.2 to this report, 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 Exhibits 99.1 and 99.2 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.
Item 8.01 Other Events.
The information set forth in Item 2.02 above is incorporated by reference into this Item 8.01.
Clinical and Research-Stage Pipeline Programs
The Company announced the following updates with respect to its clinical and research-stage pipeline programs:
? In its Imagine-1 clinical trial, it expects to dose the first patients in
cohorts 2 and 3 in early 2022.
? The target of its previously undisclosed program in adult central nervous
system disorders is PRKN for Parkinson's disease.
For its metachromatic leukodystrophy ("MLD") program (PBML04), the Company's
current approach is to use 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-dependently reduced functional decline and increased survival in a novel
MLD mouse model. The company plans to submit an Investigational New 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 Company's
current approach is to use ICM route of administration and AAV delivery of a
? miRNA and gene combination to knockdown mutant and replace with functional
MFN2. Preclinical pilot data identified lead construct that ameliorates distal
limb weakness (grip strength) after ICV delivery in mice with a mutation in the
MFN2 gene.
For its amyotrophic lateral sclerosis ("ALS") program (PBAL05), the Company's
current approach is to use ICM route of administration and AAV delivery of a
? miRNA and gene combination to knockdown mutant and replace with functional
C9orf72. Preclinical pilot data showed that AAV-C9miRNA normalized elevated
toxic poly(GP) dipeptide repeat protein levels in mouse brains with a mutation
in the C9-ALS gene. 2 Manufacturing
The Company expects to operationalize a new pilot manufacturing suite by
year-end 2022 at the Princeton West Innovation Campus in
Item 9.01Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1Passage Bio, Inc. press release datedJanuary 10, 2022 . 99.2 Corporate Presentation. 104 Cover Page Interactive Data File (formatted as Inline XBRL). 3
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