Core Insights - iBio, Inc. has announced promising pharmacokinetics data for IBIO-600, a long-acting anti-myostatin antibody, suggesting a potential human half-life of up to 130 days, which could position it as a best-in-class treatment for muscle preservation and weight loss [1][4][5] - The company is on track to submit a regulatory application for IBIO-600 in Q1 2026, highlighting its commitment to innovation in obesity treatment [1][5] Group 1: IBIO-600 Development - The pharmacokinetics study involved non-human primates (NHPs) and indicated a half-life of 40 to 52 days in NHPs, with human estimates ranging from 57 to 130 days [4] - The study demonstrated a dose-dependent increase in lean mass and a reduction in fat mass, with the low-dose group showing a 3.1% increase in lean mass and the high-dose group a 5.1% increase after 8 weeks [3] - The potential for a dosing schedule of once every 3 to 6 months could significantly reduce the treatment burden for patients [4][5] Group 2: Activin E Antibody - iBio has also disclosed preclinical data for a first-in-class Activin E antibody, which effectively blocks Activin E signaling and shows promise as a novel obesity treatment [5] - In an exploratory study with obese mice, the Activin E antibody as a monotherapy resulted in a 4% fat-selective weight loss and an 18% reduction in total body fat compared to placebo [5] - When combined with semaglutide, the Activin E antibody enhanced total weight loss by an additional 9%, leading to an overall weight reduction of 34% and a 72% reduction in body fat [5]

BOSTON, April 02, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (NASDAQ:PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today announced that Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer, will participate in a fireside chat at the Stifel 2025 Virtual Targeted Oncology Forum on Wednesday, April 9, 2025, at 11:30 a.m. ET. The Company will also be holding one-on-one investor meetings at the event. A live webcast and ...

Company Overview - ADC Therapeutics SA is a commercial-stage global leader in the field of antibody drug conjugates (ADCs) [3] - The company is focused on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [3] Recent Developments - CEO Ameet Mallik will present a company overview at the 24th Annual Needham Virtual Healthcare Conference on April 8, 2025, at 8:00 a.m. ET [1] - A live webcast of the presentation will be available on the company's website, with a replay accessible for approximately 30 days [2] Product Pipeline - ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy [4] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [4] - The company has multiple ADCs in ongoing clinical and preclinical development [4] Company Operations - ADC Therapeutics is headquartered in Lausanne, Switzerland, with operations in London, the San Francisco Bay Area, and New Jersey [5]

Core Insights - Avidity Biosciences has completed enrollment in the FORTITUDE biomarker cohort for delpacibart braxlosiran (del-brax), targeting accelerated approval for treating facioscapulohumeral muscular dystrophy (FSHD) [1][2] - The company plans to present topline data from the FORTITUDE trial in Q2 2025, with regulatory alignment anticipated for a global Phase 3 trial [1][6] - Del-brax aims to be the first approved therapy for FSHD, a rare disease affecting approximately 45,000 to 87,000 individuals in the U.S. and EU [2][10] Company Overview - Avidity Biosciences focuses on RNA therapeutics, specifically Antibody Oligonucleotide Conjugates (AOCs™), to address rare neuromuscular diseases [11] - The company is advancing clinical programs for multiple conditions, including myotonic dystrophy type 1 and Duchenne muscular dystrophy, alongside FSHD [11] Clinical Trial Details - The FORTITUDE trial is a Phase 1/2 randomized, placebo-controlled study evaluating del-brax in 90 participants with FSHD [3] - The trial assesses safety, tolerability, pharmacokinetics, and pharmacodynamics, using biomarkers like DUX4-regulated genes and MRI measures [3][4] - The ongoing biomarker cohort evaluates del-brax at a dose of 2 mg/kg every six weeks for 12 months, focusing on changes in DUX4-regulated gene expression [5] Efficacy and Safety Data - Initial data from the 2 mg/kg dose of del-brax show over 50% reductions in DUX4-regulated genes, alongside trends of functional improvement and favorable safety [2][9] - The trial's design includes three dose cohorts, with the 2 mg/kg every six weeks identified for future studies [4] Future Plans - Avidity aims to share additional data and key milestones from the del-brax program in Q2 2025, including regulatory updates and topline results [2][6]

Financial Data and Key Metrics Changes - MacroGenics reported total revenue of $150 million for the year ended December 31, 2024, compared to $58.7 million for the year ended December 31, 2023, representing a significant increase primarily due to a net increase of $85 million in revenue recognized from milestones achieved under the Incyte License Agreement [24][25] - Research and development expenses were $177.2 million for the year ending December 31, 2024, compared to $166.6 million for the year ending December 31, 2023, reflecting increased costs related to MGC028 and lorigerlimab [25][26] - The net loss was $67 million for the year ended December 31, 2024, compared to a net loss of $9.1 million for the year ended December 31, 2023 [27] - Cash, cash equivalents, and marketable securities balance as of December 31, 2024, was $201.7 million, down from $229.8 million as of December 31, 2023, with an anticipated cash runway extending into the second half of 2026 [27][28] Business Line Data and Key Metrics Changes - Revenue from collaborative and other agreements was $118.9 million, with net sales contributing $16.4 million and contract manufacturing revenue at $13.1 million for the year ended December 31, 2024 [25] - The company plans to initiate the LINNET Phase 2 study for lorigerlimab, targeting unmet needs in platinum-resistant ovarian cancer and clear cell gynecologic cancer, with enrollment expected to commence by mid-2025 [11][12] Market Data and Key Metrics Changes - The ongoing LORIKEET Phase 2 trial for lorigerlimab has completed enrollment, with a primary endpoint of radiographic progression-free survival (rPFS) [10] - The TAMARACK Phase 2 study results for vobramitamab duocarmazine (vobra duo) showed a median rPFS of 9.5 months for the 2.0 mg/kg cohort and 10.0 months for the 2.7 mg/kg cohort in patients with metastatic castration-resistant prostate cancer (mCRPC) [21][22] Company Strategy and Development Direction - MacroGenics aims to advance its diverse clinical portfolio, focusing on antibody-based cancer treatments, with significant milestones achieved in 2024 and plans for continued progress in 2025 [7][29] - The company is exploring potential alternatives for partnering the vobra duo program while continuing to develop the anti-B7-H3 ADC MGC026 [22][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's innovative pipeline and the potential for lorigerlimab in previously untreated areas of ovarian cancer and clear cell gynecologic cancers [42][44] - The board is actively searching for a successor to the CEO, with a commitment to support the company during the transition [31] Other Important Information - The company completed the sale of MARGENZA to TerSera Therapeutics in the fourth quarter, providing non-dilutive capital to support clinical pipeline investments [31] - The anticipated funding requirements reflect expected expenditures related to ongoing clinical studies, including the LORIKEET study [28] Q&A Session Summary Question: What are the gating factors to starting the LINNET study? - Management indicated that the standard-of-care for later-line ovarian cancer is low, with overall response rates of 10% to 15% for anti-PD-1 therapies, and they are optimistic about the potential of lorigerlimab in this setting [35] Question: Can you discuss the rationale behind developing lorigerlimab in ovarian and clear cell gynecologic cancers? - The management highlighted that lorigerlimab targets T-cells in the tumor microenvironment, which may lead to better outcomes compared to existing checkpoint inhibitors [42][44] Question: How does the rPFS data for vobra duo clarify the path forward for MGC026? - Management noted that MGC026 is different from vobra duo, with a different linker and payload, and they believe it has the potential for activity beyond what was observed with vobra duo [49][50] Question: What are the expectations for the discontinuation rate in the LORIKEET study? - Management expects better tolerability with lorigerlimab compared to prior checkpoint inhibitors, anticipating a lower discontinuation rate [82] Question: How far along is the Phase 1 study for MGC028? - The Phase 1 study for MGC028 has just begun, and while they are not pre-selecting patients based on ADAM9 expression, they are focusing on tumor types known for upregulation [87][88]

Absci (ABSI) Q4 2024 Earnings Call March 18, 2025 04:30 PM ET Company Participants Alexander Khan - VP of Finance & Head of Investor RelationsSean McClain - Founder, CEO & DirectorZach Jonasson - Chief Financial Officer & Chief Business OfficerChristian Stegmann - Senior Vice President of Drug CreationArseniy Shabashvili - Vice PresidentJacqueline Kisa - Equity Research AssociateDebanjana Chatterjee - Director Conference Call Participants None - AnalystVikram Purohit - AnalystGil Blum - Senior AnalystRamaka ...

Financial Data and Key Metrics Changes - As of December 31, 2024, the company ended the year with $100.6 million in cash, cash equivalents, and investments, a decrease from $174.5 million at the end of 2023 [29] - Total revenue for 2024 was $138.1 million, compared to $101.2 million for the corresponding period in 2023, attributed to collaborations with BMS, Moderna, Astellas, and Regeneron [32] - Total operating expenses for 2024 were $113.1 million, an increase from $107.7 million in 2023, primarily due to a $5 million milestone payment for CX-2051 [33] Business Line Data and Key Metrics Changes - The lead program, CX-2051, is a first-in-class ADC targeting EPCAM, with a focus on colorectal cancer, which has a significant unmet need [7][13] - CX-801, a masked version of interferon alpha, is also progressing well in early clinical trials, with plans to initiate combination therapy with KEYTRUDA in 2025 [24] Market Data and Key Metrics Changes - The global unmet need in colorectal cancer is significant, with over 1.9 million new cases annually and limited new treatments emerging in the last two decades [13] - The company is focusing on late-line CRC patients who have generally received at least three prior systemic therapies, indicating a high unmet need in this patient population [15][70] Company Strategy and Development Direction - The company is prioritizing its lead programs, CX-2051 and CX-801, to extend its cash runway to Q2 2026 and support key clinical milestones [8][29] - The strategy includes a focus on antibody masking technology and collaborations with major pharmaceutical companies to enhance its pipeline [7][25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the initial clinical data for CX-2051 and CX-801 expected in 2025, which could drive significant near-term value creation [8][28] - The company remains committed to disciplined capital allocation and resource management to progress its promising pipeline [34] Other Important Information - The company achieved a $5 million milestone in its collaboration with Astellas, indicating ongoing progress in its partnerships [31][25] - The company is not pre-selecting patients based on EPCAM expression or other disease characteristics in its Phase 1 study for CX-2051, aiming to characterize the drug across the full CRC population [15][56] Q&A Session Summary Question: Update on CX-2051 patient enrollment and data expectations - Management anticipates a meaningful update including initial safety profile characterization and potential antitumor activity data [41][42] Question: Timing for CX-801 and KEYTRUDA combination therapy - The initiation of the KEYTRUDA combination is expected in the second half of the year, likely before data presentation [45] Question: Therapeutically active doses in CX-2051 trial - A significant number of patients will be treated with doses predicted to be within the therapeutic active range by the time data is shared [51] Question: Expectations regarding KRAS status and liver metastases - There is no obvious biology suggesting a connection between KRAS status and EPCAM expression; the study aims to enroll a broad patient population [55] Question: Expression levels of EPCAM in CRC - EPCAM is highly expressed in colorectal cancer, and the clinical results are expected to validate this [61] Question: Focus on CRC for EPCAM targeting - The focus on CRC is due to its high and consistent EPCAM expression, significant unmet need, and the drug's design being optimized for this indication [70]

CytomX Therapeutics (CTMX) Q4 2024 Earnings Call March 06, 2025 05:00 PM ET Company Participants Chris Ogden - Chief Financial OfficerSean A. McCarthy - Chairman & CEOPriyanka Grover - Vice President - Biotechnology Equity ResearchDaniel Smith - Equity Research Associate Conference Call Participants Roger Song - Senior Equity Research AnalystJoseph Catanzaro - Director & Senior Equity AnalystPeter Lawson - Analyst Operator Good afternoon, everyone. Thank you for standing by. Welcome to the CytomX Therapeuti ...

Zymeworks Inc. (NASDAQ:ZYME) Q4 2024 Earnings Conference Call March 5, 2025 4:30 PM ET Company Participants Shrinal Inamdar - Director, Investor Relations Leone Patterson - Executive Vice President, Chief Business and Financial Officer Paul Moore - Chief Scientific Officer Kenneth Galbraith - Chair and Chief Executive Officer Conference Call Participants Stephen Willey - Stifel Yigal Nochomovitz - Citi Brian Cheng - JPMorgan Jonathan Miller - Evercore ISI Jay Olson - Oppenheimer & Co. Justin Zelin - BTIG Op ...

Call Start: 8:30 January 1, 0000 9:04 AM ET Compugen Ltd. (NASDAQ:CGEN) Q4 2024 - Earnings Conference Call March, 04, 2025, 8:30 AM ET Company Participants Yvonne Naughton - VP, Head of IR and Corporate Communications Anat Cohen-Dayag - President and CEO David Silberman - CFO Michelle Mahler - Chief Medical Officer Eran Ophir - Chief Scientific Officer Conference Call Participants Karina Rabayeva – Truist Securities Daina Graybosch - Leerink Partners Leland Gershell - Oppenheimer Tony Butler - Rodman and Re ...