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Passage BIO(PASG) - 2021 Q4 - Annual Report
2022-03-03 12:30
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 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, 2021 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 82-2729751 (State or other ...
Passage Bio (PASG) Presents At 2022 WORLD Symposium Data Conference
2022-02-14 18:09
| --- | --- | --- | --- | |---------------------------------------------------------------|-------|-------|----------------------------------------------| | | | | | | | | | PBGM01 Study in Infantile GM1 Gangliosidosis | | | | | | | Interim Safety, Biomarker and Efficacy Results from Low Dose, | | | | | | | | | | Late Infantile Cohort of Ongoing Imagine-1 Clinical Study | | | | | | | | | | | | | | | February 11, 2022 | | | | | | | | | | | | | | | | | | | 2 Welcome & Agenda Bruce Goldsmith, Ph.D. Chief Execut ...
Passage Bio (PASG) Presents At J.P. Morgan 40th Annual Healthcare Conference
2022-02-03 20:15
J.P. Morgan 40th Annual Healthcare Conference Bruce Goldsmith, Ph.D. President and Chief Executive Officer January 10, 2022 2 Forward-Looking Statement This presentation includes "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 expectation about timing and execution of anticipated milestones, including our planned initiation of clinical trials and the availability o ...
Passage BIO(PASG) - 2021 Q3 - Earnings Call Transcript
2021-11-06 21:22
Passage Bio, Inc. (NASDAQ:PASG) Q3 2021 Results Conference Call November 4, 2021 8:30 AM ET Company Participants Stuart Henderson - VP, IR and Strategic Finance Bruce Goldsmith - President and CEO Eliseo Salinas - Chief Research and Development Officer Simona King - CFO Conference Call Participants Tessa Romero - JP Morgan Neena Bitritto-Garg - Citi Laura Chico - Wedbush Yun Zhong - BTIG Danielle Brill - Raymond James Brendan Smith - Cowen Operator Good morning, and welcome to the Passage Bio Third Quarter ...
Passage BIO(PASG) - 2021 Q3 - Earnings Call Presentation
2021-11-04 20:32
Fulfilling the Promise of Genetic Medicines for Central Nervous System Disorders Corporate Presentation November 2021 NASDAQ GS: PASG 2 Forward-Looking Statement This presentation includes "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 expectation about timing and execution of anticipated milestones, including our planned initiation of clinical trials and the avai ...
Passage BIO(PASG) - 2021 Q3 - Quarterly Report
2021-11-04 12:07
(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q 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 ...
Passage Bio (PASG) Investor Presentation - Slideshow
2021-10-08 15:43
Fulfilling the Promise of Genetic Medicines for Central Nervous System Disorders Corporate Presentation October 2021 NASDAQ GS: PASG 2 Forward-Looking Statement This presentation includes "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 expectation about timing and execution of anticipated milestones, including our planned initiation of clinical trials and the avail ...
Passage BIO(PASG) - 2021 Q2 - Earnings Call Transcript
2021-08-08 17:39
Financial Data and Key Metrics Changes - The company ended the quarter with cash, cash equivalents, and marketable securities of approximately $408 million, compared to $305 million as of December 31, 2020, indicating a strong cash position [30] - R&D expenses increased to $33.1 million for the quarter ended June 30, compared to $19.9 million for the same quarter in 2020, primarily due to increased clinical manufacturing costs and personnel-related expenses [31] - G&A expenses rose to $15.4 million for the quarter ended June 30, compared to $7.4 million for the same quarter in 2020, driven by increased personnel-related expenses and professional fees [32] - The net loss for the second quarter of 2021 was $48.4 million, compared to $27.2 million in the same quarter of 2020, with a net loss per share of $0.90 compared to $0.60 in the prior year [33] Business Line Data and Key Metrics Changes - The company has exercised seven options in rare monogenic diseases out of a total of 17 in its agreement with the Gene Therapy Program, with a focus on expanding into larger CNS indications [11][12] - The company is initiating research programs focusing on Alzheimer's disease and Temporal Lobe Epilepsy, while maintaining its focus on rare monogenic disorders [35] Market Data and Key Metrics Changes - The company has a global network of multiple clinic sites across nine countries and three continents for its clinical programs, despite challenges due to COVID-19 [19] - The company is advancing site initiation processes for its clinical trials, with expectations to dose the first patients in the upliFT-D and GALC studies in the third quarter of 2021 [36] Company Strategy and Development Direction - The company is focused on four strategic pillars: partnership with Penn's Gene Therapy Program, a robust pipeline, integrated manufacturing supply chain, and a solid corporate foundation [7] - The recent amendment to the collaboration with GTP broadens the scope to include larger CNS diseases, which is seen as a significant inflection point for the company [9][10] - The company aims to balance its pipeline by adding non-monogenic, non-pediatric, and non-rare indications to diversify opportunities [78] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the potential of its clinical programs and the advancements in gene therapy for CNS disorders, despite ongoing delays due to COVID-19 [16][35] - The company is committed to advancing its early-stage programs and evaluating other potential options in the rare monogenic CNS space [35] Other Important Information - The company announced the appointment of new executives, including a Chief Commercial Officer and a Chief Financial Officer, to strengthen its leadership team [14][15] - The passing of co-founder Tachi Yamada was acknowledged, highlighting his significant impact on the company and the industry [38][39] Q&A Session Summary Question: Has the second patient in the Phase I/II infantile GM1 study been dosed? - The company has not yet dosed the second patient and is focusing on opening additional sites for patient enrollment [44][46] Question: Are there any delays in the FTD study? - Management indicated that site activation has faced idiosyncratic changes, but they are progressing with site initiation activities [53][54] Question: What are the expectations beyond safety for the GM1 study? - The company will provide safety updates and 30-day biomarker data in the fourth quarter, with ongoing follow-up for several years [67][68] Question: What is the competitive landscape for the FTD program? - Management noted that their gene therapy approach aims to achieve significantly higher levels of progranulin compared to competitors' monoclonal antibody treatments [85][86] Question: How is early symptomatic FTD defined in the upliFT-D study? - The study focuses on early onset symptomatic patients with specific CDR scores and NfL levels to select an optimal patient population [92][94]
Passage BIO(PASG) - 2021 Q2 - Quarterly Report
2021-08-05 12:01
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 June 30, 2021 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 82-2 ...
Passage BIO(PASG) - 2021 Q1 - Earnings Call Transcript
2021-05-09 11:08
Passage Bio, Inc. (NASDAQ:PASG) Q1 2021 Earnings Conference Call May 5, 2021 8:30 AM ET Company Participants Stuart Henderson - Vice President of Investor Relations and Strategic Finance Bruce Goldsmith - President and Chief Executive Officer Richard Morris - Chief Financial Officer Eliseo Salinas - Chief Research and Development Officer Gary Romano - Chief Medical Officer Jill Quigley - Chief Operating Officer Conference Call Participants Anupam Rama - JPMorgan Chase & Co. Salveen Richter - Goldman Sachs Y ...