Workflow
Therapy
icon
Search documents
Asia Deep Dive_ Akeso & Innovent
2025-07-07 00:51
Asia Pacific Equity Research July 2025 Asia Deep Dive: Akeso & Innovent China Healthcare Research Yang HuangAC, PhD (852) 2800 3812 yang.huang@jpmorgan.com J.P. Morgan Securities (Asia Pacific) Limited/ J.P. Morgan Broking (Hong Kong) Limited Eric Zhao, CFA (86-21) 6106 6256 eric.zhao@jpmorgan.com SAC Registration Number: S1730524050001 J.P. Morgan Securities (China) Company Limited Derek Choi, CPA (852) 2800-8744 derek.c.choi@jpmorgan.com J.P. Morgan Securities (Asia Pacific) Limited/ J.P. Morgan Broking ( ...
Passage Bio (PASG) Earnings Call Presentation
2025-07-04 12:39
PBFT02 Development and Preclinical Results - PBFT02 is an AAV gene therapy designed to deliver functional PGRN to the brain for the treatment of FTD-GRN [13] - In Grn-/- mice, AAV.hGRN vector ICV administration improved lysosomal function, reduced lipofuscin fluorescence in the thalamus, and reduced brain hexosaminidase activity [21, 23] - AAV1 was selected as the vector serotype due to superior hPGRN levels in CSF compared to AAV5 and AAVhu68 in NHPs [28, 29] - In Grn-/- mice, PBFT02 reduced lipofuscin deposition and neuroinflammation in the brain after intra-CSF delivery [34, 37] - ICM administration of PBFT02 enables PGRN delivery throughout the CNS [40] - In NHPs, PBFT02 dose-dependently increased PGRN in CSF up to day 14 [46, 48] - In NHPs, PBFT02 at Dose 1 resulted in approximately 10e4 GC/ug DNA throughout the brain [43] Clinical Trial (upliFT-D) and Safety - The upliFT-D trial is a global Phase 1/2 multi-center, open-label, dose-escalation study with PBFT02 [52, 55] - FTD-GRN Cohort 1 (n = 5) dosing is complete [56] - All four Cohort 1 participants who received a revised immunosuppression regimen had no SAEs or significant immune responses [57] - Cohort 1 interim data shows PBFT02 administration leads to robust and sustained increases in CSF PGRN [58]
Cartesian Therapeutics (SELB) Earnings Call Presentation
2025-07-04 09:55
Pipeline and Clinical Trials - Cartesian Therapeutics is pioneering mRNA cell therapies for autoimmunity, with multiple anticipated near-term catalysts[5] - Phase 3 AURORA study of Descartes-08 for Myasthenia Gravis (MG) is expected to commence in 1H25[8] - An open-label Phase 2 trial of Descartes-08 in Systemic Lupus Erythematosus (SLE) is ongoing, with data readout expected in 2H25[8] - A Phase 2 pediatric basket trial, including juvenile SLE, juvenile MG, and other conditions, is expected to initiate in 2H25[8, 12] - Dosing is underway in a first-in-human Phase 1 dose escalation trial for Descartes-15, a next-generation mRNA CAR-T candidate[8] Descartes-08 Efficacy and Safety - In a Phase 2b trial, participants treated with Descartes-08 maintained deep and durable responses over 12 months[16] - At Month 4, participants in the primary efficacy dataset experienced an average MG-ADL reduction of 5.5 points[23] - 33% of participants achieved minimum symptom expression at Month 6[23] - 80% of participants reaching Month 12 maintained a clinically meaningful response[23] - In participants with no prior exposure to biologics, the average MG-ADL reduction was 6.6 points at Month 4[26] - 57% of participants with no prior exposure to biologics achieved minimum symptom expression at Month 6[26] - 100% of participants with no prior exposure to biologics reaching Month 12 maintained a clinically meaningful response[26] - The safety profile of Descartes-08 supports outpatient administration, with no new types of adverse events reported[16, 28] Financial Position - Cartesian Therapeutics has a strong balance sheet with approximately $220.9 million as of September 30, 2024[9] - This is expected to support planned operations, including completion of the planned Phase 3 trial of Descartes-08 for MG, into mid-2027[9]
Legend Biotech (LEGN) Earnings Call Presentation
2025-07-04 08:54
Legend Biotech CORPORATE PRESENTATION JULY 2025 The safety and efficacy of the agents and/or uses under investigation discussed in this presentation have not been established, except to the extent specifically provided by marketing authorizations previously received from relevant health authorities. Further, for investigational agents and/or uses, the Company cannot guarantee health authority approval or that such agents and/or uses will become commercially available in any country. Certain information cont ...
BioNTech (BNTX) Earnings Call Presentation
2025-07-03 14:26
Oncology Pipeline & Strategy - BioNTech has a multiplatform oncology portfolio with over 20 ongoing Phase 2 or 3 trials[7] - BNT327, a PD-L1/VEGF-A antibody, is a priority program with potential as a next-generation IO-backbone, with clinical activity observed across multiple indications in over 750 patients enrolled in 20+ clinical trials[7, 19, 20] - BNT327 combined with chemo in 1L TNBC showed an objective response rate (ORR) of 769% in PD-L1 negative, 563% in PD-L1 low, and 100% in PD-L1 high patients[25] - FixVac and iNeST are novel mRNA cancer immunotherapies targeting tumor-associated antigens and cancer mutations[7, 37] COVID-19 Vaccine & Financials - BioNTech anticipates maintaining a high market share in the U S, EU, and Japan for its COVID-19 vaccine[49] - The company expects total revenues between €1700 million and €2200 million for the financial year 2025[51] - R&D expenses for FY 2025 are projected to be between €2600 million and €2800 million[51] - SG&A expenses are estimated to be between €650 million and €750 million, with capital expenditure for operating activities between €250 million and €350 million[51] Financial Position - As of December 31, 2024, BioNTech's total cash plus security investments amounted to €174 billion, including €97619 million in cash and cash equivalents, €65362 million in current security investments, and €10611 million in non-current security investments[7, 8]
IGM Biosciences (IGMS) FY Earnings Call Presentation
2025-07-03 13:17
Global Leaders in IgM Antibodies JP Morgan Healthcare Conference January 12, 2022 Forward-looking statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect the current views of IGM Biosciences, Inc. (the "Company," "we" or "our") with respect to the Company's future financial condition, results of operations, business strategy, expectations, milestones and plans. All statements other than statements of historica ...
IceCure Reports Preliminary Financial Results for the Three and Six Months Ended June 30, 2025
Prnewswire· 2025-07-03 12:30
CAESAREA, Israel, July 3, 2025 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced preliminary financial results as of and for the three and six months ended June 30, 2025.The Company expects product sales of approximately $525,000 for the three months ended June 30, 2025. While order flow was not impacted by th ...
X @Bloomberg
Bloomberg· 2025-07-03 10:08
Here's how blood restriction therapy can help a patient redevelop muscle after surgery https://t.co/fllztUmML7 ...
Xilio Therapeutics (XLO) Earnings Call Presentation
2025-07-03 06:50
Unleashing the Potential of Immuno-Oncology Therapies June 5, 2025 © 2025 Xilio Therapeutics, Inc. 1 Forward-Looking Statements and Disclaimers This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans, timing and expectations related to: development timelines and anticipated milestones for Xilio's programs; the receipt of future contingent payments under Xilio's coll ...
Equestrianism and Health | Vianne Tsai | TEDxHuawen Global Institute Youth
TEDx Talks· 2025-07-02 15:42
Increase public awareness of equine therapy, highlighting the unique value and benefits of horses in children's education and therapy. Equestrianism and Health - Interview with Equestrian Coaches This talk was given at a TEDx event using the TED conference format but independently organized by a local community. Learn more at https://www.ted.com/tedx ...