Workflow
Passage BIO(PASG) - 2024 Q3 - Quarterly Report
PASGPassage BIO(PASG)2024-11-13 12:15

Financial Performance - The net loss for the three months ended September 30, 2023, was 19,340,000,comparedtoanetlossof19,340,000, compared to a net loss of 27,110,000 for the same period last year, representing a 28.5% improvement[12]. - The net loss per share for the three months ended September 30, 2023, was (0.31),comparedto(0.31), compared to (0.49) for the same period last year[12]. - Comprehensive loss for the three months ended September 30, 2023, was 19,241,000,comparedto19,241,000, compared to 26,962,000 for the same period last year, indicating a 28.5% reduction[12]. - For the nine months ended September 30, 2024, the net loss was 52,042thousand,adecreasefromanetlossof52,042 thousand, a decrease from a net loss of 85,304 thousand for the same period in 2023, representing a 39% improvement[19]. - For the three months ended September 30, 2024, the net loss was 19.3million,comparedtoanetlossof19.3 million, compared to a net loss of 27.1 million for the same period in 2023, representing a 29% improvement[155]. - For the nine months ended September 30, 2024, the net loss was 52.0million,downfrom52.0 million, down from 85.3 million in the same period in 2023, indicating a 39% reduction in losses[155]. - As of September 30, 2024, the accumulated deficit stood at 646.5million[155].ResearchandDevelopment−ResearchanddevelopmentexpensesforthethreemonthsendedSeptember30,2023,were646.5 million[155]. Research and Development - Research and development expenses for the three months ended September 30, 2023, were 8,656,000, while for the nine months ended, they totaled 30,621,000[12].−Researchanddevelopmentexpensesdecreasedby30,621,000[12]. - Research and development expenses decreased by 6.4 million to 8.7millionforthethreemonthsendedSeptember30,2024,from8.7 million for the three months ended September 30, 2024, from 15.1 million for the same period in 2023[186]. - Research and development expenses decreased by 18.6millionto18.6 million to 30.6 million for the nine months ended September 30, 2024, from 49.3millionforthesameperiodin2023[195].−Thecompanyhaspauseddevelopmentofcertainresearchprogramstoreduceoperatingexpenses,specificallyaprogramforTLE[154].−Researchanddevelopmentexpensesareanticipatedtoremainconsistentinthenearfuture,withpotentialincreasesasproductcandidatesprogressintolater−stageclinicaltrials[180].CashFlowandLiquidity−ThetotalaccumulateddeficitasofSeptember30,2023,was49.3 million for the same period in 2023[195]. - The company has paused development of certain research programs to reduce operating expenses, specifically a program for TLE[154]. - Research and development expenses are anticipated to remain consistent in the near future, with potential increases as product candidates progress into later-stage clinical trials[180]. Cash Flow and Liquidity - The total accumulated deficit as of September 30, 2023, was (646,510,000)[15]. - Cash and cash equivalents at the end of the period were 32,292thousand,slightlydownfrom32,292 thousand, slightly down from 33,579 thousand at the end of the previous period[19]. - The company had cash, cash equivalents, and marketable securities totaling 84.8millionasofSeptember30,2024,expectedtofundoperationsuntiltheendofQ22026[158].−ThenetcashusedinoperatingactivitiesfortheninemonthsendedSeptember30,2024,was84.8 million as of September 30, 2024, expected to fund operations until the end of Q2 2026[158]. - The net cash used in operating activities for the nine months ended September 30, 2024, was 39,512 thousand, compared to 58,748thousandforthesameperiodin2023,indicatinga3358,748 thousand for the same period in 2023, indicating a 33% reduction in cash outflow[19]. - The company expects existing cash and marketable securities will fund operating expenses and capital expenditures until the end of the second quarter of 2026[203]. Impairment and Expenses - The company reported an impairment of long-lived assets amounting to 4,795,000 for the three months ended September 30, 2023[12]. - The Company recognized impairment expenses for property and equipment of 2.3millionand2.3 million and 2.7 million for the three and nine months ended September 30, 2024, respectively, compared to 3.2millionforthesameperiodsin2023[39].−TheCompanyrecognizedanimpairmentexpenseof3.2 million for the same periods in 2023[39]. - The Company recognized an impairment expense of 4.8 million related to certain asset groups, including 2.5millionforROUassetsand2.5 million for ROU assets and 2.3 million for property and equipment, during the three and nine months ended September 30, 2024[88]. - Impairment expense of long-lived assets recorded was 4.8millionduringthethreemonthsendedSeptember30,2024,comparedto4.8 million during the three months ended September 30, 2024, compared to 5.4 million for the same period in 2023[192][193]. - Impairment expense of long-lived assets recorded was 5.2millionduringtheninemonthsendedSeptember30,2024,comparedto5.2 million during the nine months ended September 30, 2024, compared to 5.4 million for the same period in 2023[199][200]. Shareholder Equity and Stock Options - The weighted average common shares outstanding for the three months ended September 30, 2023, were 61,763,346, an increase from 54,789,410 shares in the prior year[12]. - The Company had 12,012,051 stock options outstanding as of September 30, 2024, with a weighted average exercise price of 3.89[118].−Thetotalunrecognizedcompensationexpenserelatedtounvestedstockoptionawardswas3.89[118]. - The total unrecognized compensation expense related to unvested stock option awards was 6.9 million, expected to be recognized over 2.3 years[118]. - The Company has 1,379,590 shares available for future grants under the 2020 Employee Stock Purchase Plan as of September 30, 2024[122]. Collaborations and Agreements - The company entered into a new research collaboration and license agreement with GEMMA Biotherapeutics and amended its collaboration with the University of Pennsylvania[21]. - The Company entered into sublicense agreements with Gemma, receiving an initial payment of 5,000,000forlicensesandclinicalproductsupply,withanadditional5,000,000 for licenses and clinical product supply, with an additional 5,000,000 due in December 2024[73]. - The Gemma Collaboration Agreement includes payments of up to 16.5millionperproductcandidateforHuntington′sdiseaseandfutureCNSindications,withadditionalsalesmilestonepaymentsofupto16.5 million per product candidate for Huntington's disease and future CNS indications, with additional sales milestone payments of up to 55.0 million based on annual worldwide net sales[163]. - The Company is obligated to make payments of up to 16.5millionperproductcandidateuponachievingspecificdevelopmentmilestonesunderthePennLicenseAgreement[96].−TheCompanyisrequiredtopaytieredroyaltiesinthemid−singledigitspercentageonannualworldwidenetsalesoflicensedproductsuponsuccessfulcommercialization[97].LegalandRegulatoryMatters−TheCompanyrecordeda16.5 million per product candidate upon achieving specific development milestones under the Penn License Agreement[96]. - The Company is required to pay tiered royalties in the mid-single digits percentage on annual worldwide net sales of licensed products upon successful commercialization[97]. Legal and Regulatory Matters - The Company recorded a 1.0 million loss contingency for a legal proceeding as of September 30, 2024[111]. - The Company is involved in litigation regarding a claim of breach of contract, with the plaintiff seeking a mid-single digit million dollar amount, and a jury awarded $1.0 million to the plaintiff on the breach of contract claim[125][126]. - The FDA has granted Orphan Drug Designation and Fast Track Designation for PBFT02 for the treatment of FTD and FTD-GRN[145]. Clinical Development - The lead clinical product candidate, PBFT02, aims to elevate progranulin levels to enhance lysosomal function and slow disease progression in neurodegenerative diseases, specifically targeting frontotemporal dementia caused by progranulin deficiency[130]. - PBFT02 has shown promising biomarker data, with cerebrospinal fluid (CSF) progranulin levels increasing from 10.7 to 27.3 ng/mL at 6 months post-treatment, significantly higher than the healthy control range of 3.3 to 8.2 ng/mL[142]. - The Company plans to initiate dosing for PBFT02 in treating FTD-C9orf72 patients in the first half of 2025 and expects regulatory feedback on the clinical pathway for ALS patients in the second half of 2024[149]. - The Company has completed dosing of Cohort 1 in the upliFT-D trial and is continuing to study Dose 1 in Cohort 2 based on robust PGRN expression observed[143]. - The Company anticipates reporting 12-month follow-up data from Cohort 1 and interim data from Cohort 2 in the first half of 2025[144].