PASSAGE BIO, INC. : Results of operations and financial situation, disclosure of FD regulations, other events, financial statements and exhibits (Form 8-K)

Item 2.02 Results of operations and financial position
At
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
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
Item 9.01 Financial statements and supporting documents.
(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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