PASG Passage Bio Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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PBGM01
GM1 gangliosidosis
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Phase 1/2
Phase 1/2
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Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
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PBKR03
Krabbe Disease
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Phase 1/2
Phase 1/2
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PBFT02
Frontotemporal dementia
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Phase 1/2
Phase 1/2
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Latest News
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PHILADELPHIA, Feb. 24, 2021 (GLOBE NEWSWIRE) -- Passage Bio, Inc. (NASDAQ:PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, today announced that it will host a conference call and live webcast at 8:30 a.m. ET on Wednesday, March 3, 2021 to report its fourth quarter and full-year 2020 financial results and discuss recent business highlights.
To access the live conference call, please dial 833-528-0605 (domestic) or 830-221-9711 (international) and refer to conference ID 6758094. A live audio webcast of the event will be available on the Investors & Media section of Passage Bio's website at investors.passagebio.com. The archived webcast will be available on Passage Bio's website approximately two hours after the completion of the event and for 30 days following the call.
About Passage Bio
At Passage Bio (NASDAQ:PASG), we are on a mission to provide life-transforming gene therapies for patients with rare, monogenic 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.
For further information, please contact:
Investors:
Stuart Henderson
Passage Bio
[email protected]Media:
Gwen Fisher
Passage Bio
215.407.1548
[email protected]
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PHILADELPHIA, Feb. 19, 2021 (GLOBE NEWSWIRE) -- Passage Bio, Inc. (NASDAQ:PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders, today announced the appointment of Maxine Gowen, Ph.D., to its board of directors, effective Feb. 18. Dr. Gowen is chief executive officer of Tamuro Bio, a post that she has held since July 2019.
"We are immensely excited to have Maxine join our board of directors," said Dr. Bruce Goldsmith, president and chief executive officer of Passage Bio. "Her public company leadership and deep clinical development expertise will provide tremendous support to Passage Bio as we transition to a clinical development organization in the first half of 2021."
Tadataka Yamada, M.D., chairman of the Passage Bio board of directors and company co- founder, added: "We are delighted to welcome Dr. Gowen to the board of directors of Passage Bio. Her extensive board and leadership experience in both large and small innovative pharmaceutical and biotech companies will be beneficial as Passage Bio continues its growth trajectory. We look forward to working with and benefiting from the experience and expertise of Dr. Gowen."
Dr. Gowen was the founding president and chief executive officer of Trevena, Inc. from 2007 to October 2018, and has served as a member of Trevena's board of directors since 2008. Dr. Gowen previously held a variety of leadership roles at GlaxoSmithKline, GSK, over a period of 15 years. As senior vice president for GSK's Center of Excellence for Drug Discovery, she developed an innovative new approach to externalizing drug discovery. She also currently serves on the boards of directors for Idera Pharmaceuticals, Inc., Akebia Therapeutics, Inc., and Aclaris Therapeutics, Inc. In addition, Dr. Gowen serves on the private company boards of directors of Tamuro Bio and Panorama Therapeutics, Inc., as well as the board of directors of Life Sciences Pennsylvania, an industry organization. Dr. Gowen graduated with a B.Sc. in biochemistry from the University of Bristol, U.K., received a Ph.D. in cell biology from the University of Sheffield, U.K., and received an M.B.A. from the Wharton School of the University of Pennsylvania.
"Passage Bio is in the vanguard of companies working to develop potentially transformative gene therapies, and I am incredibly excited to be able to join and contribute to the board at such a pivotal time in the company's journey," Dr. Gowen said.
Stephen Squinto, Ph.D., Resigns from Passage Bio Board of Directors
Dr. Gowen's appointment comes as Stephen Squinto, Ph.D., resigns from Passage Bio's board of directors and as acting head of Research & Development for the company. Steve was a co- founder of Passage Bio who also served as interim chief executive officer at the formation of the company through January 2020. During Steve's tenure, Passage Bio worked closely with the University of Pennsylvania's Gene Therapy Program to advance our pipeline, raised substantial funding, established the leadership team and supported the company's Initial Public Offering.
"I am proud of where Passage Bio stands today with a strong management team, expansion of the clinical, manufacturing and operations team and an extremely sound financial position," said Dr. Squinto. "I leave my positions optimistic about the future of the company as it continues to make significant progress in developing gene therapies with the potential of transforming lives of patients with rare CNS disorders."
"We are grateful for Dr. Squinto's instrumental work in setting up Passage Bio to eventually become an independent publicly traded company and supporting the initial growth of the company infrastructure," said Dr. Yamada. "We wish Dr. Squinto continued success as he turns his focus to other responsibilities, including his full-time role as executive partner at OrbiMed."
About Passage Bio
At Passage Bio (NASDAQ:PASG), we are on a mission to provide life-transforming gene therapies for patients with rare, monogenic 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 our planned IND submissions, 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 the underlying causes of 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:
Sarah McCabe and Zofia Mita
Stern Investor Relations, Inc.
212-362-1200
[email protected]
[email protected]Passage Bio Media:
Gwen Fisher
Passage Bio
215-407-1548
[email protected] -
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- Phase 1/2 trial expected to commence in first half of 2021
- Company has three INDs cleared for rare monogenic CNS disorders
PHILADELPHIA, Feb. 08, 2021 (GLOBE NEWSWIRE) -- Passage Bio, Inc. (NASDAQ:PASG), a genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for PBKR03, an adeno-associated virus (AAV)-delivery gene therapy being studied for the treatment of early infantile Krabbe disease (Globoid Cell Leukodystrophy). Currently, there are no approved disease-modifying therapies available for Krabbe disease, a rare lysosomal storage disease that most often presents early in a child's life, resulting in rapid progressive damage to both the brain and peripheral nervous system and mortality by two years of age. Underscoring the urgent medical need in the patient population, the FDA has previously granted Passage Bio both Orphan Drug and Rare Pediatric Disease designations for PBKR03 for treatment in Krabbe disease.
"As part of our commitment to deliver a transformative, one-time gene therapy to the children and their families who suffer from the devastating effects of Krabbe disease, we are excited to advance toward clinically evaluating the potential life-changing benefits of PBKR03," said Bruce Goldsmith, Ph.D., chief executive officer of Passage Bio. "The FDA clearance of our IND for PBKR03 is an important milestone for Passage Bio, paving the way for the start of our third clinical program in rare monogenic CNS disorders in the first half of 2021. Having solidified our clinical trial preparedness and manufacturing readiness during the past year, we are well-positioned to move with urgency to advance PBKR03 into the clinic."
PBKR03 utilizes a next-generation proprietary AAV capsid to deliver, through intra-cisterna magna (ICM) administration, a functional GALC gene to Krabbe patients with mutations in the gene that codes for galactosylceramidase (GAL-C). Low GAL-C activity results in accumulation of psychosine which is toxic to the myelin-producing oligodendrocytes of the CNS and Schwann cells in the periphery, resulting in damage to both the central and peripheral nervous systems. PBKR03 has the potential to treat both the central nervous system and peripheral nerve manifestations observed in Krabbe disease patients.
Compelling preclinical data support advancement into clinical trials
PBKR03 is supported by extensive preclinical studies, conducted by our collaborator, the University of Pennsylvania's Gene Therapy Program, showing meaningful transduction of both the central and peripheral nervous system in animal models, with restoration of myelination in the brain and peripheral nerves. In a naturally occurring Krabbe animal model, a single ICM injection of an AAVhu68 capsid containing the normal canine GALC gene showed normalization of GALC activity, reduction of cerebral spinal fluid psychosine levels, normalization of peripheral nerve conduction velocity, improvement in brain myelination, reduction in brain inflammation and increased survival.
Phase 1/2 study anticipated for 1H21
Passage Bio expects to initiate a Phase1/2 clinical trial for PBKR03 in the first half of 2021. The trial is designed as a dose escalation study of a single ICM dose of PBKR03 in pediatric subjects with early infantile Krabbe disease. The primary endpoint of the Phase 1/2 study is safety and tolerability; secondary endpoints include CSF and serum GALC levels, disease biomarkers, and clinical outcome measures. Initial data from the trial is anticipated to potentially readout in late 2021 or early 2022, depending on the timing of when the first patient is treated in the study.
PENN Financial Disclosure
The University of Pennsylvania (Penn) and its Gene Therapy Program receives sponsored research funding from Passage Bio, and Penn has licensed intellectual property to Passage Bio that may result in future financial returns to Penn.
About Krabbe Disease
Krabbe disease is a rare and often life-threatening lysosomal storage disease caused by mutations in the GALC gene, which encodes galactosylceramidase, an enzyme that breaks down galactosylceramide and psychosine. Without adequate levels of galactosylceramidase, psychosine accumulates, causing widespread death of myelin-producing cells and progressive damage to nerves in both the brain and peripheral tissues. The early infantile form of the disease is the most severe and common, typically manifesting before six months of age and accounting for 60 percent to 70 percent of diagnoses. In these patients, the disease course is highly predictable and rapidly progresses to include loss of acquired milestones, staring episodes, apnea, peripheral neuropathy, severe weakness, unresponsiveness to stimuli, seizures, blindness, deafness and eventual death by two years of age. Late infantile patients, defined by onset between seven to twelve months of age, present similar symptoms and have a median survival of approximately five years from onset of symptoms. The estimated worldwide incidence of Krabbe disease is 2.6 in 100,000 births, which is higher than reported due to lack of adequate screening at birth.
About Passage Bio
At Passage Bio (NASDAQ:PASG), we are on a mission to provide life-transforming gene therapies for patients with rare, monogenic 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 our planned IND submissions, 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 the underlying causes of 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:
Sarah McCabe and Zofia Mita
Stern Investor Relations, Inc.
212-362-1200
[email protected]
[email protected]Passage Bio Media:
Gwen Fisher
Passage Bio
215-407-1548
[email protected] -
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– Second Product Candidate Expected to Enter Clinic in First Half of 2021
– Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options
PHILADELPHIA, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Passage Bio, Inc. (NASDAQ:PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for PBFT02, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of patients with Frontotemporal Dementia (FTD) with granulin (GRN) mutations. FTD is a debilitating form of early onset dementia that currently has no approved disease-modifying therapies.
"We are pleased to be advancing our second therapy into clinical development in our quest to bring transformative medicines to patients who need them," said Bruce Goldsmith, Ph.D., chief executive officer of Passage Bio. "FTD can have a devastating impact on a person's quality of life and create a substantial caregiving and economic burden for families. We are excited to investigate the potential of PBFT02 as a treatment for FTD-GRN as we initiate our clinical development program in the coming months."
FTD is one of the more common causes of early-onset (midlife) dementia, causing impairment in behavior, language and executive function, and occurs at similar frequency to Alzheimer's disease in patients younger than 65 years. In approximately 5 to 10 percent of individuals with FTD – 3,000 to 6,000 in the United States – the disease occurs because of mutations in the GRN gene, causing a deficiency of progranulin (PGRN). PGRN is a complex and highly conserved protein. The mechanism by which PGRN deficiency results in FTD is uncertain, but increasing evidence points to PGRN's role in lysosomal function. The rapid progression of FTD results in an average survival of eight years after onset of symptoms.
Passage Bio is developing PBFT02 to treat FTD-GRN as a single dose delivered via intra-cisterna magna (ICM) injection. The gene therapy utilizes an AAV1 viral vector to deliver a modified DNA encoding the GRN gene to a patient's cells. The goal of this vector and delivery approach is to provide higher than normal levels of PGRN to the central nervous system to overcome the progranulin deficiency in GRN mutation carriers, who have been observed to have reduced cerebrospinal fluid PGRN levels ranging from 30% to 50% of the PGRN levels observed in normal, mutation non-carriers.
Clinical Development of PBFT02 Supported by University of Pennsylvania's Gene Therapy Program (GTP) Pre-Clinical Data
Passage Bio is advancing PBFT02 into the clinic supported by preclinical data generated by its collaborator, University of Pennsylvania's Gene Therapy Program (GTP). The data, published in the peer-reviewed scientific journal Annals of Clinical and Translational Neurology, showed that a single administration of an optimized AAV containing the GRN gene resulted in elevated levels of PGRN in the brain and cerebral spinal fluid (CSF), reduced lysosomal storage lesions, normalized lysosomal enzyme expression and corrected microgliosis in a mouse model of progranulin deficiency. A single administration of PBFT02 via the optimized AAV1-GRN vector demonstrated transduction broadly across the brain, including a very high transduction of ependymal cells that line the ventricles of the brain and are involved with CSF production, resulting in CSF progranulin levels of more than 50-fold normal.
The FDA has granted an Orphan Drug designation for PBFT02 for the treatment of FTD-GRN.
Phase 1/2 Study Initiation Anticipated for 1H21
Passage Bio expects to initiate a Phase1/2 clinical trial for PBFT02 in the first half of 2021. The trial is designed as a dose-escalation study of a single ICM dose of PBFT02 in subjects with FTD and heterozygous mutations in the GRN gene. The primary endpoint of the Phase 1/2 study is safety and tolerability; secondary endpoints include CSF progranulin levels, disease biomarkers, and clinical outcome measure. Initial data from the trial is anticipated to potentially readout in late 2021 or early 2022, depending on the timing of when the first patient is treated in the study.
About Passage Bio
At Passage Bio (NASDAQ:PASG), we are on a mission to provide life-transforming gene therapies for patients with rare, monogenic 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 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 our planned IND submissions, 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 the underlying causes of 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:
Sarah McCabe and Zofia Mita
Stern Investor Relations, Inc.
212-362-1200
[email protected]
[email protected]Passage Bio Media:
Gwen Fisher
Passage Bio
215-407-1548
[email protected] -
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PHILADELPHIA, Jan. 21, 2021 (GLOBE NEWSWIRE) -- Passage Bio, Inc. (NASDAQ:PASG), a genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system disorders, today announced the pricing of its underwritten public offering of 7,000,000 shares of its common stock at a public offering price of $22.00 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $154.0 million. All shares of common stock to be sold in the offering will be sold by Passage Bio. In addition, Passage Bio has granted the underwriters a 30-day option to purchase up to an additional 1,050,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about January 26, 2021, subject to the satisfaction of customary closing conditions.
J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC and Cowen and Company, LLC are acting as the joint bookrunning managers for the offering. Wedbush Securities Inc. and Chardan are acting as co-managers for the offering.
The offering is being made only by means of a prospectus. A copy of the final prospectus may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at [email protected].
A registration statement relating to the sale of these securities has been filed with, and declared effective by, the Securities and Exchange Commission (SEC). This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Passage Bio
At Passage Bio (NASDAQ:PASG), we are on a mission to provide life-transforming gene therapies for patients with rare, monogenic central nervous system 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 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.
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, statements regarding the expected gross proceeds, satisfaction of the closing conditions and our ability to complete the public offering. 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 our filings with the SEC, including the Risk Factors section in our Registration Statement on Form S-1 filed with the SEC on January 19, 2021, and other reports as filed with the SEC. We undertake 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:
Sarah McCabe and Zofia Mita
Stern Investor Relations, Inc.
212-362-1200
[email protected]
[email protected]Passage Bio Media:
Gwen Fisher
Passage Bio
215-407-1548
[email protected]