Passage Bio Provides Update on Strategic Priorities and Extends Cash Runway
Passage Bio (Nasdaq: PASG) announced a strategic restructuring to extend its cash runway by reducing its workforce by 13% and focusing on key R&D programs. The company is advancing three clinical trials for GM1 gangliosidosis, Krabbe disease, and frontotemporal dementia. The estimated cash runway is now extended into Q2 2024. Key leadership changes include the retirement of Chief Research and Development Officer Eliseo O. Salinas, effective March 18, 2022, with Mark Forman continuing to lead the trials. Upcoming milestones include patient dosing and IND submissions in 2022.
- Workforce reduction of 13% aims to decrease operating expenses and extend cash runway into Q2 2024.
- Continued focus on three key clinical trials for GM1 gangliosidosis, Krabbe disease, and frontotemporal dementia.
- Workforce reduction may affect company morale and project continuity.
- Retirement of Chief Research and Development Officer could lead to disruptions in management.
- Company to reduce workforce and prioritize research and development programs to reduce operating expenses
- Continued focus on execution of three ongoing clinical trials for GM1 gangliosidosis, Krabbe disease and frontotemporal dementia
- Estimated cash runway extended into Q2 2024
PHILADELPHIA, March 15, 2022 (GLOBE NEWSWIRE) -- 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 Bio
At 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 Statements
This 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 Henderson
Passage Bio
267-866-0114
shenderson@passagebio.com
Passage Bio Media:
Mike Beyer
Sam Brown Inc. Healthcare Communications
312-961-2502
MikeBeyer@sambrown.com
FAQ
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