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Passage BIO(PASG) - 2025 Q1 - Quarterly Report
PASGPassage BIO(PASG)2025-05-13 11:15

Financial Performance - As of March 31, 2025, Passage Bio reported total assets of 86.0million,downfrom86.0 million, down from 102.4 million as of December 31, 2024, representing a decrease of approximately 16%[13] - The company incurred a net loss of 15.4millionforthethreemonthsendedMarch31,2025,animprovementfromanetlossof15.4 million for the three months ended March 31, 2025, an improvement from a net loss of 16.7 million for the same period in 2024, reflecting a reduction of about 7.8%[14] - The accumulated deficit as of March 31, 2025, was 674.6million,upfrom674.6 million, up from 659.2 million at the end of 2024, indicating an increase of approximately 2.2%[13] - The company reported a comprehensive loss of 15.4millionforQ12025,comparedtoacomprehensivelossof15.4 million for Q1 2025, compared to a comprehensive loss of 16.7 million in Q1 2024, showing an improvement of about 7.8%[14] - The Company recorded a net loss per share for the three months ended March 31, 2025, with basic and diluted loss per share being the same due to the anti-dilutive effect of potential securities[62] - The Company recorded a loss from operations of 16.5millionforthethreemonthsendedMarch31,2025,comparedtoalossof16.5 million for the three months ended March 31, 2025, compared to a loss of 18.1 million for the same period in 2024[190] - The company used 13.8millioninnetcashforoperatingactivitiesinQ12025,reflectinganetlossof13.8 million in net cash for operating activities in Q1 2025, reflecting a net loss of 15.4 million[206] - Cash used in operating activities in Q1 2024 was 18.9million,reflectinganetlossof18.9 million, reflecting a net loss of 16.7 million[207] Cash and Liquidity - Cash and cash equivalents increased to 63.4millionasofMarch31,2025,comparedto63.4 million as of March 31, 2025, compared to 37.6 million at the end of 2024, marking a growth of about 68.6%[13] - As of March 31, 2025, the company's total cash and cash equivalents amounted to 63.357million,anincreasefrom63.357 million, an increase from 37.573 million as of December 31, 2024, reflecting a significant growth of 68.6%[66] - The company had cash and cash equivalents of 63.4millionasofMarch31,2025,expectedtofundoperationsintoQ12027[166]−Thecompanyhas63.4 million as of March 31, 2025, expected to fund operations into Q1 2027[166] - The company has 15.8 million remaining capacity to offer and sell shares under the ATM Facility as of March 31, 2025[203] - The company currently has no credit facility or committed sources of capital, indicating a need for additional funds for operational needs and clinical trials[201] Research and Development - Research and development expenses decreased to 7.7millioninQ12025from7.7 million in Q1 2025 from 11.5 million in Q1 2024, indicating a reduction of approximately 33%[14] - Total research and development expenses for the three months ended March 31, 2025, were 7.737million,downfrom7.737 million, down from 11.535 million in the same period of 2024, indicating a reduction of about 33.5%[133] - The Company’s research and development costs primarily consist of expenses related to contract research organizations and internal activities, with estimates made based on progress to completion[48] - The company expects research and development expenses to decrease in the near future due to a 55% reduction in workforce and cessation of lab operations in January 2025[183] - The lead clinical product candidate, PBFT02, aims to elevate progranulin levels to enhance lysosomal function and slow disease progression in neurodegenerative diseases, with a focus on frontotemporal dementia (FTD) caused by progranulin deficiency[137] - PBFT02 is currently in clinical development for FTD-GRN, with plans to expand its use to other adult neurodegenerative diseases, including FTD-C9orf72 and ALS, based on positive regulatory feedback[138] Impairment and Expenses - The Company recognized impairment expenses of 2.6millionforlaboratoryequipmentandcertainotherassetsforthethreemonthsendedMarch31,2025,comparedtonoimpairmentexpensesforthesameperiodin2024[43]−Thecompanyrecordedanimpairmentof2.6 million for laboratory equipment and certain other assets for the three months ended March 31, 2025, compared to no impairment expenses for the same period in 2024[43] - The company recorded an impairment of 2.6 million related to the remeasurement of long-lived assets, which was included in the statement of operations for the three months ended March 31, 2025[70] - The Company recorded severance and termination-related costs of 1.7millionforthethreemonthsendedMarch31,2025,comparedtonosuchcostsinthesameperiodof2024[79]−TheCompanyrecordedshare−basedcompensationexpenseof1.7 million for the three months ended March 31, 2025, compared to no such costs in the same period of 2024[79] - The Company recorded share-based compensation expense of 858,000 for the three months ended March 31, 2025, compared to 1.595millionforthesameperiodin2024,reflectingadecreaseofapproximately46.31.595 million for the same period in 2024, reflecting a decrease of approximately 46.3%[120] - General and administrative expenses decreased by 0.4 million to 6.1millionforthethreemonthsendedMarch31,2025,from6.1 million for the three months ended March 31, 2025, from 6.5 million in the same period of 2024[192] Funding and Future Plans - The company plans to seek additional funding through public or private equity offerings, debt financings, and strategic alliances, with 15.8millionremainingavailableunderitsATMFacilityasofMarch31,2025[29][30]−Futurefundingrequirementswilldependonvariousfactors,includingtheprogressofclinicaltrialsandcollaborationswiththirdparties[200]−Theongoingclinicaltrialsandresearchprogramsareexpectedtoincursignificantexpenses,withtheneedforadditionalcapitaltosupportoperationsandgrowthstrategies[165]−Thecompanyanticipatesanincreaseingeneralandadministrativeexpensesifproductcandidatesprogressintolater−stageclinicaltrialsandrequirecommercializationefforts[187]LeaseandSubleaseAgreements−TheCompanyhasclassifiedallleaseswithtermsgreaterthanoneyearasoperatingleasesasofMarch31,2025[45]−TheCompanyhasatotalundiscountedleaseliabilityof15.8 million remaining available under its ATM Facility as of March 31, 2025[29][30] - Future funding requirements will depend on various factors, including the progress of clinical trials and collaborations with third parties[200] - The ongoing clinical trials and research programs are expected to incur significant expenses, with the need for additional capital to support operations and growth strategies[165] - The company anticipates an increase in general and administrative expenses if product candidates progress into later-stage clinical trials and require commercialization efforts[187] Lease and Sublease Agreements - The Company has classified all leases with terms greater than one year as operating leases as of March 31, 2025[45] - The Company has a total undiscounted lease liability of 25.116 million, with future minimum lease payments totaling 40.205million[93]−TheCompanyenteredintoasubleaseagreementforapproximately29,000squarefeetwithabaserentof40.205 million[93] - The Company entered into a sublease agreement for approximately 29,000 square feet with a base rent of 0.9 million per year, effective from March 1, 2024, through August 2026[84] - The Company subleased approximately 16,000 square feet with a base rent of 0.3millionperyear,startingMarch26,2024,andexpiringSeptember30,2025[86]−Thecompanyhasaleaseobligationofapproximately0.3 million per year, starting March 26, 2024, and expiring September 30, 2025[86] - The company has a lease obligation of approximately 11.8 million for office space in Philadelphia, expiring in December 2031, with potential cash inflows from sublease agreements[211] Clinical Trials and Product Development - The estimated prevalence of FTD-GRN in the US and Europe is approximately 18,000, while FTD-C9orf72 is estimated at 21,000[145][155] - In the upliFT-D trial, Dose 1 of PBFT02 resulted in robust increases in cerebrospinal fluid (CSF) PGRN levels, from below 3.0 ng/mL at baseline to 22.3 to 34.0 ng/mL at 12 months post-treatment[146] - Plasma neurofilament light chain (NfL) levels decreased by an average of 13% at 12 months post-treatment with Dose 1 of PBFT02, contrasting with an expected 29% annual increase in untreated patients[148] - The company plans to report 12-month follow-up data from Dose 1 and interim safety and biomarker data from Dose 2 in the second half of 2025[153] Collaboration Agreements - The Company has entered into sublicense agreements with Gemma Biotherapeutics for multiple gene therapy programs, including treatments for GM1 gangliosidosis, Krabbe disease, and metachromatic leukodystrophy[139] - The Gemma Collaboration Agreement requires payments of up to 16.5millionperproductcandidateforHuntington′sdiseaseand16.5 million per product candidate for Huntington's disease and 39.0 million for Temporal Lobe Epilepsy[102] - Under the Gemma Sublicenses, the company is entitled to receive initial payments of 10millionanduptoanadditional10 million and up to an additional 114 million in development and commercial milestone payments[176] - The Amended Catalent Agreements establish a limited exclusive relationship for the manufacture of drug products for adeno-associated virus delivery therapeutic candidates until November 6, 2030[180]