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Passage BIO(PASG) - 2024 Q2 - Quarterly Results
2024-08-08 11:00
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]
Passage Bio to Participate in Upcoming Investor Conferences
Newsfilter· 2024-08-06 11:00
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]
Passage Bio Out-licenses Three Pediatric Gene Therapy Programs to GEMMA Biotherapeutics and Enters New Research Collaboration
GlobeNewswire News Room· 2024-08-01 11:00
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, ...
Passage Bio Announces Positive Feedback from FDA on Expansion of upliFT-D Trial of PBFT02 to Include FTD-C9orf72 Patients
Newsfilter· 2024-07-16 11:00
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]
Passage Bio Announces Positive Feedback from FDA on Expansion of upliFT-D Trial of PBFT02 to Include FTD-C9orf72 Patients
GlobeNewswire News Room· 2024-07-16 11:00
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 Announces Recipient of Third Annual Tachi Yamada Scholarship Award
Newsfilter· 2024-05-21 12:00
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 ...
All You Need to Know About Passage Bio (PASG) Rating Upgrade to Buy
zacks.com· 2024-05-16 17:01
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].
Passage BIO(PASG) - 2024 Q1 - Quarterly Report
2024-05-14 11:15
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-39231 PASSAGE BIO, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 82- ...
Passage BIO(PASG) - 2024 Q1 - Quarterly Results
2024-05-14 11:01
PASSAGE BIO REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS AND PROVIDES RECENT BUSINESS HIGHLIGHTS PHILADELPHIA – May 14, 2024 – Passage Bio, Inc. (Nasdaq: PASG), a clinical stage genetic medicines company focused on improving the lives of patients with neurodegenerative diseases, today reported financial results for the first quarter ended March 31, 2024 and provided recent business highlights. "The beginning of 2024 has been marked by strong execution as we continue to advance our global upliFT-D clinical t ...
Passage BIO(PASG) - 2023 Q4 - Annual Report
2024-03-04 12:15
FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF For the transition period from to Commission File Number 001-39231 PASSAGE BIO, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 82-2729751 (State or other juris ...