Passage Bio Culls 13% of Headcount, Prioritizes Gene Therapy 

Job Cuts

Less than one week after dosing the first patient in a Phase I/II gene therapy trial for early infantile Krabbe disease, Passage Bio announced it was cutting its headcount by 13% in order to preserve cash runway.

Shares of the Philadelphia-based company were falling in premarket trading in response to the announcement. In addition to terminating 13% of its headcount, Passage Bio said it will also reprioritize its research and development programs in partnership with the University of Pennsylvania’s Gene Therapy Program. The company will continue to focus on advancing its three lead clinical programs for GM1 gangliosidosis, Krabbe disease and frontotemporal dementia.

Bruce Goldsmith, president and chief executive officer of Passage Bio, said the tough decision to initiate layoffs and reduce operating expenses, along with the decision to align its partnership with the University’s gene therapy program, will provide the company with the ability to “execute against our ongoing clinical trials and advance our mission.”

“We are committed to our mission of developing transformative therapies for people with devastating CNS disorders,” Goldsmith said in a statement.

In its fourth-quarter and year-end financial report announced March 3, Passage Bio said its cash and cash equivalents as of Dec. 31, 2021 were $315.8 million. At the time, the company said that the cash position provided it with enough funds to finance operations to year-end 2023.

The job losses are not just impacting the rank and file employees. Passage Bio’s chief research and development officer Eliseo O. Salinas will be departing from the company effective March 18. Chief Medical Officer Mark Forman will guide the company’s ongoing clinical trials, Passage Bio said.

“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,” Goldsmith added.

The cuts are expected to provide the company with enough cash runway to extend into the fourth quarter of 2024. They will provide the company with the financial flexibility to achieve expected upcoming milestones that include the presentation of interim safety and biomarker data from Cohort 1 of the Krabbe disease study by year-end.

That study is assessing PBKR03, an adeno-associated virus (AAV)-delivery gene therapy for Krabbe disease, a rare pediatric lysosomal storage disorder caused by mutations in the GALC gene. Early infantile Krabbe disease is typically fatal, with a life expectancy of about two years.

The gene therapy being studied in this trial is designed to administer a functional GALC gene to patients with mutations in the gene that codes for galactosylceramidase. Passage Bio said PBKR03 has the potential to treat both the central nervous system and peripheral nerve manifestations that are typically seen in patients with Krabbe disease.

Other expected milestones include plans to dose the first patient in a Phase I/II study for frontotemporal dementia in the first part of 2022, as well as presenting safety and biomarker data from Cohort 2 and 3 in the company’s ongoing GM1 gangliosidosis study. Cohort 2 is investigating a high dose of PBGM01, an AAV-delivery gene therapy in late infantile patients, and Cohort 3 is assessing a low dose in early infantile patients.

The company also expects to submit an Investigational New Drug Application for Phase I/II study for PBML04 in metachromatic leukodystrophy in the middle of this year.

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