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Zenas BioPharma, Inc.(ZBIO) - 2025 Q1 - Earnings Call Presentation
2025-05-15 12:55
Zenas BioPharma Enabling patients with autoimmune diseases to reimagine life Corporate Presentation May 2025 1 Disclaimer FORWARD-LOOKING STATEMENTS: This presentation contains "forward-looking statements" which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts cont ...
Jade Biosciences Reports First Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-05-14 20:05
Completed reverse merger and commenced trading on Nasdaq as JBIO Closed financing, raising approximately $300 million to date, providing cash runway through 2027 Lead candidate JADE101 expected to enter the clinic in second half of 2025, with interim biomarker-rich data expected in first half of 2026 SAN FRANCISCO and VANCOUVER, British Columbia, May 14, 2025 (GLOBE NEWSWIRE) -- Jade Biosciences, Inc. (“Jade”) (Nasdaq: JBIO), a biotechnology company focused on developing best-in-class therapies for autoimmu ...
Nektar(NKTR) - 2025 Q1 - Earnings Call Transcript
2025-05-08 22:02
Nektar Therapeutics (NKTR) Q1 2025 Earnings Call May 08, 2025 05:00 PM ET Company Participants Corinne Franklin - Investor RelationsHoward Robin - President and Chief Executive OfficerJonathan Zalevsky - Chief Research & Development OfficerSandra Gardiner - Chief Financial OfficerJulian Harrison - Managing DirectorMayank Mamtani - Senior Managing DirectorYu He - VP - Equity Research Conference Call Participants Yasmeen Rahimi - Sr. Research AnalystJay Olson - Managing Director & Senior Analyst - Biotechnolo ...
Immunic to Participate in Scientific and Industry Conferences in May
Prnewswire· 2025-05-02 10:30
NEW YORK, May 2, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific and industry conferences in May: May 3-6: Digestive Disease Week (DDW). Two abstracts discussing Immunic's phase 1/1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 ...
Immunic Announces Vidofludimus Calcium Reduced Risk of Disability Worsening by 30% in Primary Progressive Multiple Sclerosis Patients from Phase 2 CALLIPER Trial
Prnewswire· 2025-04-30 11:30
– Reduced Relative Risk of 24-Week Confirmed Disability Worsening Events by 20% in Overall Study Population Compared to Placebo; Even More Prominent 30% Reduction in High Unmet Need Population of Primary Progressive Multiple Sclerosis –– Showed Consistent Reduction of Disability Worsening in Subpopulations Without Inflammatory Lesions at Baseline in Overall Study Population; Reduced Relative Risk of 24-Week Confirmed Disability Worsening Events in Patients Without Gadolinium-Enhancing Lesions at Baseline by ...
Cartesian Therapeutics’ Descartes-08 Observed to Provide Deep and Sustained Benefits Through Month 12 After a Single Course of Therapy in Phase 2b Myasthenia Gravis Trial
Globenewswire· 2025-04-08 11:00
Core Insights - Cartesian Therapeutics announced positive 12-month efficacy and safety data from the Phase 2b trial of Descartes-08 for generalized myasthenia gravis (MG), showing sustained symptom improvement in participants [2][4][9] - Descartes-08 demonstrated a significant average reduction in MG-ADL scores, particularly in patients without prior biologic therapy, indicating its potential as a transformative treatment option [9][11] Efficacy Results - Participants treated with Descartes-08 experienced an average MG-ADL reduction of 4.8 points at Month 12, with deeper responses observed over time [7][11] - In the subgroup of participants without prior biologic therapy, the average MG-ADL reduction was 7.1 points at Month 12, with 57% maintaining minimum symptom expression [11] - 83% of evaluable participants maintained a clinically meaningful response through Month 12, defined as a reduction of at least 2 points in MG-ADL [7] Safety Profile - The safety profile of Descartes-08 was consistent with previously reported data, supporting its outpatient administration without the need for preconditioning chemotherapy [4][10] - Adverse events were mostly mild and transient, with no new adverse events reported during the 12-month follow-up [10][11] Future Development - The Phase 3 AURORA trial is on track to dose the first patient in the second quarter of 2025, with the trial design accepted by the FDA under the Special Protocol Assessment process [9][14] - Descartes-08 has received Regenerative Medicine Advanced Therapy and Orphan Drug Designations from the FDA, highlighting its potential in treating MG [9][13]
Cartesian Therapeutics' Descartes-08 Observed to Provide Deep and Sustained Benefits Through Month 12 After a Single Course of Therapy in Phase 2b Myasthenia Gravis Trial
Newsfilter· 2025-04-08 11:00
Core Insights - Cartesian Therapeutics announced positive 12-month efficacy and safety data from the Phase 2b trial of Descartes-08 for generalized myasthenia gravis (MG) [2][4] - Descartes-08 demonstrated sustained symptom improvement with an average reduction of 4.8 points in MG Activities of Daily Living (MG-ADL) at Month 12 [6][8] - The therapy showed particularly strong results in participants without prior exposure to biologic therapies, achieving an average 7.1-point reduction in MG-ADL [10] Efficacy Results - In the Phase 2b trial, participants receiving Descartes-08 experienced deep responses, with an average MG-ADL reduction of 5.5 at Month 4 and 4.8 at Month 12 [6][4] - 83% of evaluable participants maintained a clinically meaningful response through Month 12, defined as a reduction of at least 2 points in MG-ADL [6] - Among participants without prior biologic therapy, 100% maintained a clinically meaningful response through Month 12 [10] Safety Profile - Descartes-08 was well-tolerated, with no new adverse events reported during the 12-month follow-up [10] - Common side effects included transient infusion-related reactions such as fever (60%), chills (60%), headache (55%), and nausea (45%), all resolving within 24 hours [10] - No cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) were reported [10] Future Developments - The Phase 3 AURORA trial is set to dose the first patient in the second quarter of 2025, following FDA agreement on the trial design [8][10] - Descartes-08 has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designations from the FDA for the treatment of MG [12][8] - The company aims to transform the treatment landscape for MG with Descartes-08, offering a safe and durable outpatient therapy option [8][10]
Nektar(NKTR) - 2024 Q4 - Earnings Call Transcript
2025-03-13 05:38
Nektar Therapeutics (NKTR) Q4 2024 Earnings Call March 13, 2025 01:38 AM ET Company Participants Vivian Wu - Director of Investor Relations & Corporate AffairsHoward W. Robin - CEO, President & DirectorBrian Kotzin - Interim Chief Medical OfficerJonathan Zalevsky - Senior VP & Chief Research and Development OfficerSandra Gardiner - Chief Financial OfficerJulian Harrison - Managing DirectorMayank Mamtani - Senior Managing Director Conference Call Participants Yasmeen Rahimi - Sr. Research AnalystJay Olson - ...
Q32 Bio Announces Late-Breaking Presentation of Results from SIGNAL-AA Part A Clinical Trial of Bempikibart in Alopecia Areata at the 2025 American Academy of Dermatology Annual Meeting
Prnewswire· 2025-02-28 14:00
Core Insights - Q32 Bio Inc. announced the presentation of Phase 2a Part A results of bempikibart for alopecia areata at the 2025 AAD Annual Meeting, highlighting its potential in treating severe cases of the disease [1][2] Group 1: Clinical Trial Details - The SIGNAL-AA Phase 2a clinical trial is a randomized, placebo-controlled study evaluating bempikibart, a fully human anti-IL-7Rα antibody [1][4] - The oral presentation will take place on March 8, 2025, from 10:36 a.m. to 10:48 a.m. ET at Chapin Theater, Level II [2] Group 2: Company Overview - Q32 Bio is a clinical stage biotechnology company focused on developing biologic therapeutics aimed at restoring immune homeostasis in autoimmune and inflammatory diseases [3][4] - Bempikibart is being evaluated for its ability to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling pathways, which are implicated in various autoimmune diseases [4]
Q32 Bio to Participate in Upcoming March Investor Conferences
Prnewswire· 2025-02-26 11:59
Core Insights - Q32 Bio Inc. is a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis [1][2] - The company will participate in two investor conferences in March 2025, providing opportunities for engagement with investors [1] Company Overview - Q32 Bio targets potent regulators of the adaptive immune system to address autoimmune and inflammatory diseases [2] - The company is advancing bempikibart (ADX-914), a fully human anti-IL-7Rα antibody, currently in a Phase 2 program for the treatment of autoimmune diseases [3] Upcoming Events - Q32 Bio will present at the TD Cowen 45th Annual Health Care Conference on March 5, 2025, at 11:50 a.m. E.T. in Boston, MA [1] - The company will also participate in the Leerink Partners Global Healthcare Conference on March 11, 2025, with a fireside chat at 11:20 a.m. E.T. in Miami Beach, FL [1] - Webcasts of the presentations will be available on the company's website, with archived replays for 90 days [1]