Core Points - Passage Bio, Inc. is a clinical stage genetic medicines company focused on neurodegenerative diseases [3] - The company will present at the Guggenheim Securities Healthcare Innovation Conference on November 13, 2024 [1] - The lead product candidate, PBFT02, aims to treat frontotemporal dementia by elevating progranulin levels [3] Company Overview - Passage Bio is dedicated to developing one-time therapies targeting the underlying pathology of neurodegenerative conditions [3] - The company emphasizes its commitment to improving the lives of patients and families affected by these diseases [3][4]

Core Insights - Passage Bio, Inc. has appointed Tom Kassberg to its Board of Directors and Audit Committee, enhancing its leadership team during a critical phase for the organization [1][2] - Mr. Kassberg brings extensive experience from Ultragenyx, where he contributed to the development of gene therapies for rare diseases, which will be beneficial for Passage Bio's strategic direction [2][3] Company Overview - Passage Bio is a clinical stage genetic medicines company focused on developing one-time therapies for neurodegenerative diseases, with its lead product candidate PBFT02 aimed at treating conditions like frontotemporal dementia [4] - The company aims to elevate progranulin levels to restore lysosomal function and slow disease progression in patients [4] Leadership Experience - Tom Kassberg has a strong background in corporate development and strategic planning, having held key positions at various biopharmaceutical companies, including Proteolix and InterMune [2][3] - His career includes significant contributions to business development and alliance management, which are expected to support Passage Bio's mission [2][3]

Financial Performance - The net loss for the six months ended June 30, 2024, was $32,702,000, compared to a net loss of $58,194,000 for the same period in 2023, reflecting an improvement of approximately 44%[10]. - The company reported a comprehensive loss of $15,989,000 for the three months ended June 30, 2024, compared to a comprehensive loss of $23,769,000 for the same period in 2023, indicating a decrease of approximately 32.9%[10]. - Net cash used in operating activities for the six months ended June 30, 2024, was $32,065,000, compared to $39,585,000 for the same period in 2023, indicating a 19% reduction[15]. - The company recorded $1.4 million in other income (expense), net for the three months ended June 30, 2024, primarily from interest income and amortization of marketable securities[41]. - For the six months ended June 30, 2024, the Company reported $2.7 million in other income (expense), net, with $2.4 million from interest income and amortization of marketable securities[42]. Assets and Liabilities - Total current assets decreased from $117,959,000 as of December 31, 2023, to $95,000,000 as of June 30, 2024, representing a decline of approximately 19.5%[8]. - Cash and cash equivalents increased from $21,709,000 as of December 31, 2023, to $24,770,000 as of June 30, 2024, a rise of approximately 14.1%[8]. - Total liabilities decreased from $39,262,000 as of December 31, 2023, to $34,835,000 as of June 30, 2024, a reduction of about 11.3%[8]. - Marketable securities decreased from $92,585,000 as of December 31, 2023, to $67,003,000 as of June 30, 2024, a decline of approximately 27.7%[8]. - Total financial assets decreased from $96,935,000 on December 31, 2023, to $75,533,000 as of June 30, 2024[52]. Research and Development - Research and development expenses for the three months ended June 30, 2024, were $10,430,000, compared to $17,324,000 for the same period in 2023, indicating a reduction of about 39.5%[10]. - Research and development expenses decreased by $12.2 million to $22.0 million for the six months ended June 30, 2024, from $34.2 million for the same period in 2023[148]. - The decrease in research and development expenses was primarily due to reductions in headcount and lower activity in supporting certain programs[145]. - The company has developed its lead clinical product candidate, PBFT02, targeting frontotemporal dementia caused by progranulin deficiency[17]. - The company plans to initiate dosing for PBFT02 in treating FTD-C9orf72 patients in the first half of 2025, following positive regulatory feedback[103]. Equity and Financing - The weighted average common shares outstanding increased from 54,683,817 for the six months ended June 30, 2023, to 58,989,007 for the same period in 2024, an increase of about 7.5%[10]. - The company issued 6,000,000 shares of common stock under the ATM Facility, resulting in net proceeds of $8.7 million after deducting offering costs[20]. - The company has $50 million of capacity remaining to offer and sell shares of common stock under the ATM Facility as of June 30, 2024[157]. - The company plans to seek additional funding through various means, including public or private equity offerings, to support its operations and product development[21]. - The company anticipates financing operations through equity offerings, debt financings, collaborations, and strategic alliances until substantial product revenue is generated[156]. Legal Matters - The company anticipates litigation with a former employee to go to trial in 2024, with claims amounting to mid-single digit millions of dollars[83]. - The court denied both the company's and the plaintiff's motions for summary judgment, and the matter is expected to go to trial in the fourth quarter of 2024[178]. - The company does not currently face any other legal proceedings that would materially adversely affect its business[179]. Operational Expenses - General and administrative expenses for the six months ended June 30, 2024, were $13,025,000, down from $27,111,000 for the same period in 2023, a decrease of about 52.0%[10]. - General and administrative expenses decreased by $1.6 million to $6.5 million for the three months ended June 30, 2024, from $8.1 million for the same period in 2023[144]. - The company recorded share-based compensation expense of $1.578 million for the three months ended June 30, 2024, compared to $3.743 million for the same period in 2023[89]. - The company expects to incur expenses related to scaling up clinical, regulatory, and manufacturing capabilities as part of its future commercialization activities[154]. - The company has an accumulated deficit of $627.2 million as of June 30, 2024, reflecting ongoing financial challenges[18].

Clinical Trials and Research - The company enrolled the first patient in Cohort 2 of the upliFT-D trial for FTD-GRN, with plans to treat three to five patients using Dose 1 of PBFT02, which has been well-tolerated in previous cohorts[1] - The company plans to present updated safety and biomarker data from Cohort 1 patients at the 14th International Conference on Frontotemporal Dementias (ISFTD2024) in September 2024[3] - The FDA has agreed to the company's proposed expansion of the ongoing upliFT-D trial to include FTD-C9orf72 patients, with dosing expected to begin in the first half of 2025[4] Financial Performance - As of June 30, 2024, the company's cash, cash equivalents, and marketable securities totaled $91.8 million, down from $151.5 million a year earlier, with a cash runway expected to last until the end of Q2 2026[4] - Research and Development (R&D) expenses for Q2 2024 were $10.4 million, a decrease from $17.3 million in Q2 2023[4] - General and Administrative (G&A) expenses for Q2 2024 were $6.5 million, down from $8.1 million in the same quarter of the previous year[4] - The net loss for Q2 2024 was $16.0 million, or $0.26 per share, compared to a net loss of $23.9 million, or $0.44 per share, for Q2 2023[4] - Total assets as of June 30, 2024, were $125.4 million, a decrease from $150.5 million at the end of 2023[8] - Total liabilities decreased to $34.8 million as of June 30, 2024, from $39.3 million at the end of 2023[8] - Research and development expenses for Q2 2024 were $10,430,000, compared to $17,324,000 in Q2 2023, representing a decrease of 39.5%[10] - General and administrative expenses for Q2 2024 were $6,510,000, down from $8,064,000 in Q2 2023, a reduction of 19.3%[10] - The net loss for Q2 2024 was $15,991,000, compared to a net loss of $23,856,000 in Q2 2023, indicating an improvement of 32.9%[10] - The net loss per share for Q2 2024 was $(0.26), an improvement from $(0.44) in Q2 2023[10] - The comprehensive loss for Q2 2024 was $15,989,000, compared to $23,769,000 in Q2 2023, showing a decrease of 32.8%[10] - Total operating loss for the first six months of 2024 was $(35,428,000), compared to $(61,271,000) for the same period in 2023, a reduction of 42.3%[10] - Other income for Q2 2024 was $1,387,000, slightly down from $1,532,000 in Q2 2023, a decrease of 9.5%[10] - The company reported an impairment of long-lived assets of $438,000 in Q2 2024, with no impairment reported in Q2 2023[10] - Unrealized gain on marketable securities for Q2 2024 was $2,000, compared to an unrealized gain of $87,000 in Q2 2023[10] Licensing and Partnerships - The company completed the out-licensing of pediatric lysosomal storage disease programs to GEMMA Biotherapeutics, receiving initial payments of $10 million and potential additional payments of up to $114 million[4]

Company Overview - Passage Bio, Inc. is a clinical-stage genetic medicines company focused on improving the lives of patients with neurodegenerative diseases [2] - The company is developing cutting-edge, one-time therapies aimed at addressing the underlying pathology of neurodegenerative conditions [2] Upcoming Events - Management will participate in the Canaccord Genuity 44th Annual Growth Conference on August 13, 2024, at 8:00 a.m. ET in Boston, MA [1] - Management will also participate in the 15th Annual Wedbush PacGrow Healthcare Conference on August 14, 2024, in New York City, NY [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for 30 days post-event [1]

Granted exclusive, worldwide rights for the development and commercialization of PBGM01 for GM1 gangliosidosis, PBKR03 for Krabbe disease, and PBML04 for metachromatic leukodystrophy to GEMMA Biotherapeutics, a new company co-founded by Dr. James M. Wilson Entered new strategic research and collaboration agreement with GEMMA Biotherapeutics to advance genetic medicines for CNS indications, including Huntington's disease Transaction expected to extend operating cash runway to the end of Q2 2026 PHILADELPHIA, ...

Core Insights - Passage Bio has received positive feedback from the FDA regarding its proposal to evaluate PBFT02 for treating frontotemporal dementia (FTD) patients with C9orf72 gene mutations, indicating alignment on the trial expansion [12] - The company plans to initiate dosing of FTD-C9orf72 patients in the first half of 2025, following the amendment of the ongoing upliFT-D Phase 1/2 global study protocol [13] Company Overview - Passage Bio is a clinical-stage genetic medicines company focused on developing therapies for neurodegenerative diseases, with PBFT02 as its lead product candidate aimed at elevating progranulin (PGRN) levels to restore lysosomal function and slow disease progression [15] - PBFT02 utilizes an AAV1 viral vector for delivering a functional GRN gene through ICM administration, targeting the underlying pathology of neurodegenerative conditions [14] Clinical Development - The FDA has granted PBFT02 Fast Track and Orphan Drug designations, which may facilitate its development and approval process [7] - Preclinical studies have shown that increasing PGRN levels can reduce TDP-43 pathology and slow neurodegeneration, supporting the potential efficacy of PBFT02 [8][12]

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 the initiation of dosing of FTDC9orf72 patients; the progress of clinical studies and the availability of clinical data from such trials; our Passage Bio Media: Mike Beyer Sam Brown Inc. Healthcare Communications 3 ...

Passage Bio first announced its plans to launch the annual Tachi Yamada Scholarship Program in October 2021 to continue the legacy of Tadataka (Tachi) Yamada, M.D., a visionary biopharma industry leader who passed away in August 2021. Dr. Yamada had a life-long devotion to mentoring and building the next generation of scientists. About Passage Bio Passage Bio (NASDAQ:PASG) is a clinical stage genetic medicines company on a mission to improve the lives of patients with neurodegenerative diseases. Our primary ...

Core Viewpoint - Passage Bio, Inc. (PASG) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, suggesting that an upward revision in earnings estimates can lead to increased buying pressure and higher stock prices [4][5]. - For the fiscal year ending December 2024, Passage Bio is expected to earn -$1.22 per share, reflecting a 34.4% change from the previous year's reported number, with a 10.9% increase in the Zacks Consensus Estimate over the past three months [8]. Zacks Rating System - The Zacks Rank stock-rating system categorizes stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7]. - The upgrade of Passage Bio to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for near-term price movement due to favorable earnings estimate revisions [11].