Passage Bio Provides Update on Strategic Priorities and Extends Cash Runway
March 15 2022 - 7:00AM
Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic
medicines company focused on developing transformative therapies
for central nervous system (CNS) disorders, today provided an
update on strategic priorities to extend its cash runway. The
company will decrease operating expenses by reducing the workforce
by approximately 13 percent and prioritizing its research and
development programs in partnership with the University of
Pennsylvania’s Gene Therapy Program (GTP). The company will
continue to focus on advancing its three lead clinical programs for
GM1 gangliosidosis, Krabbe disease and frontotemporal dementia.
“We are committed to our mission of developing transformative
therapies for people with devastating CNS disorders,” said Bruce
Goldsmith, Ph.D., president and chief executive officer, Passage
Bio. “We have made the strategic decision to focus our
organizational priorities, reduce our operating expenses and invest
in the highest value development activities. By aligning our
organization and our foundational partnership with GTP around a
more focused R&D strategy, we are well-positioned to execute
against our ongoing clinical trials and advance our mission.”
In conjunction with the headcount reduction, Eliseo O. Salinas,
M.D., MSc, chief research and development officer, will be retiring
and departing from the Company effective March 18, 2022. Mark
Forman, M.D., Ph.D., chief medical officer, will continue to lead
execution of the ongoing clinical trials. Dr. Forman joined the
company in July 2021 with 20 years of experience in translational
research for neurological disorders in both corporate and academic
settings.
“While it will be difficult to part with these talented members
of our team, we want to thank them for their important
contributions to Passage as we continue to pursue our mission to
deliver medicines that provide a cure for previously incurable
diseases,” added Dr. Goldsmith.
Anticipated Upcoming Milestones:
- Dose first patient in Phase 1/2 study for FTD-GRN in early
2022. Additional clinical data milestone timing to be provided
following dosing of first patients.
- Submit Investigational New Drug application for Phase 1/2
clinical program for PBML04 (metachromatic leukodystrophy) in
mid-2022.
- Present interim safety and biomarker data for Cohorts 2 (late
infantile, high dose) and 3 (early infantile, low dose) for
Imagine-1 clinical trial for GM1 in 2H 2022.
- Present interim safety and biomarker data for Cohort 1 for
GALax-C clinical trial for Krabbe disease by YE 2022.
About Passage BioAt Passage Bio (Nasdaq: PASG),
we are on a mission to provide life-transforming genetic medicines
for patients with CNS diseases that replace their suffering with
boundless possibility, all while building lasting relationships
with the communities we serve. Based in Philadelphia, PA, our
company has established a strategic collaboration and licensing
agreement with the renowned University of Pennsylvania’s Gene
Therapy Program to conduct our discovery and IND-enabling
preclinical work. This provides our team with enhanced access to a
broad portfolio of gene therapy candidates and future gene therapy
innovations that we then pair with our deep clinical, regulatory,
manufacturing and commercial expertise to rapidly advance our
robust pipeline of optimized gene therapies into clinical testing.
As we work with speed and tenacity, we are always mindful of
patients who may be able to benefit from our therapies. More
information is available at www.passagebio.com.
Forward-Looking StatementsThis press release
contains “forward-looking statements” within the meaning of, and
made pursuant to the safe harbor provisions of, the Private
Securities Litigation Reform Act of 1995, including, but not
limited to: our expectations about timing and execution of
anticipated milestones, including initiation of clinical trials and
the availability of clinical data from such trials; our
expectations about our collaborators’ and partners’ ability to
execute key initiatives; our expectations about manufacturing plans
and strategies; our expectations about cash runway; and the ability
of our lead product candidates to treat their respective target
monogenic CNS disorders. These forward-looking statements may be
accompanied by such words as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,”
“might,” “plan,” “potential,” “possible,” “will,” “would,” and
other words and terms of similar meaning. These statements involve
risks and uncertainties that could cause actual results to differ
materially from those reflected in such statements, including: our
ability to develop and obtain regulatory approval for our product
candidates; the timing and results of preclinical studies and
clinical trials; risks associated with clinical trials, including
our ability to adequately manage clinical activities, unexpected
concerns that may arise from additional data or analysis obtained
during clinical trials, regulatory authorities may require
additional information or further studies, or may fail to approve
or may delay approval of our drug candidates; the occurrence of
adverse safety events; the risk that positive results in a
preclinical study or clinical trial may not be replicated in
subsequent trials or success in early stage clinical trials may not
be predictive of results in later stage clinical trials; failure to
protect and enforce our intellectual property, and other
proprietary rights; our dependence on collaborators and other third
parties for the development and manufacture of product candidates
and other aspects of our business, which are outside of our full
control; risks associated with current and potential delays, work
stoppages, or supply chain disruptions caused by the coronavirus
pandemic; and the other risks and uncertainties that are described
in the Risk Factors section in documents the company files from
time to time with the Securities and Exchange Commission (SEC), and
other reports as filed with the SEC. Passage Bio undertakes no
obligation to publicly update any forward-looking statement,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
For further information, please contact:
Passage Bio Investors:Stuart HendersonPassage
Bio267-866-0114shenderson@passagebio.com
Passage Bio Media:Mike BeyerSam Brown Inc.
Healthcare Communications312-961-2502MikeBeyer@sambrown.com
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