CARMEL, Ind., Oct. 20, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced that Kent Hawryluk, President and Chief Executive Officer, and Sam Azoulay, M.D., Chief Medical Officer, will present at and participate in the following upcoming investor conferences: Guggenheim 2nd Annual Healthcare Innovation Confe ...

Core Insights - MBX Biosciences, Inc. is set to announce topline results from its Phase 2 clinical trial of canvuparatide for chronic hypoparathyroidism on September 22, 2025 [1] - The company will host a conference call and webcast to discuss the trial results, accessible via a live link or by phone [2] - MBX Biosciences focuses on developing precision peptide therapies for endocrine and metabolic disorders using its proprietary PEP™ platform [3] Company Overview - MBX Biosciences is a clinical-stage biopharmaceutical company dedicated to discovering and developing novel therapies for endocrine and metabolic disorders [3] - The company is advancing a pipeline of candidates targeting significant unmet medical needs with large market opportunities [3]

Core Insights - MBX Biosciences has initiated a Phase 1 clinical trial for MBX 4291, a novel glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) co-agonist prodrug aimed at treating obesity, marking a significant milestone in addressing global obesity issues [2][6] - The trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MBX 4291, with topline results expected in 2027 [2][9] - MBX 4291 is positioned as a best-in-class weight loss prodrug, with potential for once-monthly administration and improved gastrointestinal tolerability compared to existing treatments [2][6] Clinical Trial Details - The Phase 1 trial consists of two parts: Part A involves single ascending doses administered to 5 cohorts of 8 participants each, followed by a 63-day observation period [2][3] - Part B includes multiple ascending doses over 4 weeks, with 3 cohorts of 8 participants each, followed by a 71-day observation period [3][4] - After Parts A and B, the company plans to evaluate multiple ascending doses over 12 weeks in up to two cohorts of 30 participants each, with a total of 12 administrations [4] Product Information - MBX 4291 is developed using the proprietary Precision Endocrine Peptide™ (PEP™) platform, designed to enhance treatment adherence and achieve greater long-term weight loss [6][7] - Preclinical studies indicate that MBX 4291 has a similar activity profile to tirzepatide, an approved weekly GLP-1/GIP co-agonist, but with an extended duration of action supporting once-monthly administration [7] - The company is also advancing other candidates in its pipeline, including canvuparatide for chronic hypoparathyroidism and imapextide for post-bariatric hypoglycemia, indicating a broad focus on endocrine and metabolic disorders [8]

Core Insights - MBX Biosciences has appointed Dr. Andreas Moraitis as Senior Vice President of Clinical Development, bringing extensive experience in endocrinology to lead the clinical development of its lead product candidate, canvuparatide [1][2] Company Overview - MBX Biosciences is a clinical-stage biopharmaceutical company focused on developing novel precision peptide therapies for endocrine and metabolic disorders, utilizing its proprietary PEP™ platform [3] - The company is advancing a pipeline that includes canvuparatide (MBX 2109) in Phase 2 for chronic hypoparathyroidism, imapextide (MBX 1416) in Phase 1 for post-bariatric hypoglycemia, and an obesity portfolio with multiple candidates in development [3] Leadership and Expertise - Dr. Moraitis has over a decade of experience in leading clinical development programs at Corcept Therapeutics, where he oversaw programs for rare endocrine diseases and supported NDA filings [2] - His background includes serving as Clinical Assistant Professor in the Endocrine Oncology Program at the University of Michigan and completing a fellowship in Adult and Reproductive Endocrinology at the National Institutes of Health [2] Product Potential - Canvuparatide is positioned as a meaningful new treatment option for patients with hypoparathyroidism, addressing significant unmet medical needs in this area [2] - The company aims to deliver differentiated endocrine and metabolic compounds to underserved patients, leveraging Dr. Moraitis's expertise to advance its pipeline [2][3]

Core Viewpoint - MBX Biosciences has submitted an Investigational New Drug (IND) application to the FDA for MBX 4291, a long-acting GLP-1/GIP receptor co-agonist prodrug aimed at treating obesity, with a Phase 1 trial expected to start in Q3 2025 [2][3][4] Company Overview - MBX Biosciences is a clinical-stage biopharmaceutical company focused on developing novel precision peptide therapies for endocrine and metabolic disorders [6] - The company is based in Carmel, Indiana, and is advancing a pipeline that includes multiple candidates for obesity and other metabolic disorders [6] Product Details - MBX 4291 is designed as a once-monthly injectable treatment for obesity, potentially offering improved gastrointestinal tolerability and better adherence compared to existing treatments [3][4] - Preclinical studies indicate that MBX 4291 has a similar activity profile and body weight loss effect as tirzepatide, an approved weekly GLP-1/GIP co-agonist, with an extended duration of action [5] Development Pipeline - The company is advancing several early-stage obesity candidates alongside MBX 4291, utilizing its proprietary PEP™ platform to create precision peptides with differentiating characteristics [3][6] - Other candidates in the pipeline include canvuparatide (MBX 2109) in Phase 2 for chronic hypoparathyroidism and imapextide (MBX 1416) in Phase 1 for post-bariatric hypoglycemia [6] Proprietary Technology - MBX's PEP™ platform is designed to enhance peptide drug design, aiming to overcome limitations of traditional peptide therapies by optimizing pharmaceutical properties such as extended action profiles and consistent drug concentrations [7]

Core Insights - MBX Biosciences, Inc. is focused on developing novel precision peptide therapies for endocrine and metabolic disorders, with a significant emphasis on post-bariatric hypoglycemia (PBH) treatment [1][6] - The company will present findings on MBX 1416 at the American Diabetes Association's 85th Scientific Sessions, highlighting its potential as a once-weekly treatment for PBH [2][1] - MBX 1416 has shown positive results in Phase 1 clinical trials, with a Phase 2 trial expected to start in the latter half of 2025 [2] Company Overview - MBX Biosciences is based in Carmel, Indiana, and utilizes its proprietary PEP™ platform to develop therapies targeting endocrine and metabolic disorders [6] - The company's pipeline includes MBX 2109 for chronic hypoparathyroidism in Phase 2, MBX 1416 for PBH in Phase 1, and an obesity portfolio with an IND filing anticipated in Q2 2025 [6] Product Details - MBX 1416 is an investigational long-acting GLP-1 receptor antagonist designed to prevent severe hypoglycemia in individuals with PBH [4] - PBH is a serious complication following bariatric surgery, characterized by recurrent hypoglycemic episodes, and currently lacks approved pharmacotherapies [5] Upcoming Presentations - Presentations on MBX 1416 will take place on June 22, 2025, during the General Poster Session at the ADA conference, featuring studies on its safety, pharmacokinetics, and effects on blood glucose levels [7]

Company Overview - MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for endocrine and metabolic disorders [3] - The company is based in Carmel, Indiana and utilizes its proprietary PEP™ platform to advance its pipeline of candidates [3] Pipeline Development - The pipeline includes canvuparatide (MBX 2109) for chronic hypoparathyroidism in Phase 2 development [3] - MBX 1416 is in Phase 1 development for post-bariatric hypoglycemia [3] - An obesity portfolio includes MBX 4291, with an IND filing anticipated in Q2 2025, along with multiple discovery and pre-clinical obesity candidates [3] Upcoming Investor Conferences - Kent Hawryluk, President and CEO, will present at the Jefferies Global Healthcare Conference on June 4, 2025, at 2:00 p.m. ET in New York, NY [1] - The company will also participate in the Goldman Sachs Global Healthcare Conference on June 9, 2025, with a podium presentation at 10:40 a.m. ET in Miami, FL [2] - Live webcasts of these events will be accessible on the MBX Biosciences website, with replays available for approximately 90 days [2]

Core Insights - MBX Biosciences is making significant progress in its clinical programs, with topline results for the Phase 2 Avail trial of canvuparatide expected in Q3 2025 and an IND submission for MBX 4291 anticipated in Q2 2025 [2][3][4] Financial Highlights - As of March 31, 2025, MBX Biosciences reported cash, cash equivalents, and marketable securities totaling $240.8 million, which is expected to support operations into mid-2027 [7][16] - Research and development expenses for Q1 2025 were $22.4 million, a significant increase from $11.0 million in Q1 2024, driven by ongoing studies for MBX 4291 and the Phase 2 Avail trial [12][16] - General and administrative expenses rose to $4.1 million in Q1 2025 from $2.3 million in Q1 2024, reflecting increased personnel-related costs [12][16] - The net loss for Q1 2025 was $23.9 million, compared to a net loss of $12.3 million for the same period in 2024 [12][16] Clinical Development Updates - The Phase 2 Avail trial for canvuparatide has completed enrollment with 64 participants, exceeding the original target, and results are expected in Q3 2025 [3][4] - MBX 4291, a GLP-1/GIP co-agonist prodrug, is being developed as a once-monthly treatment for obesity, with an IND application submission on track for Q2 2025 [4][8] - A Phase 2 trial for MBX 1416, targeting post-bariatric hypoglycemia, is expected to begin in the second half of 2025 following successful Phase 1 results [5][8] Corporate Developments - Steve Hoerter has been appointed as an independent director to the board, bringing extensive pharmaceutical leadership and commercialization experience [6][8]

Company Overview - MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for endocrine and metabolic disorders [3] - The company is based in Carmel, Indiana and utilizes its proprietary PEP™ platform to advance its pipeline of candidates [3] Pipeline Development - The pipeline includes canvuparatide (MBX 2109) for chronic hypoparathyroidism in Phase 2 development [3] - MBX 1416 is in Phase 1 development for post-bariatric hypoglycemia [3] - An obesity portfolio includes MBX 4291, with an IND submission anticipated in Q2 2025, along with multiple discovery and pre-clinical obesity candidates [3] Upcoming Events - Kent Hawryluk, President and CEO, will present at the Citizens Life Sciences Conference on May 7, 2025, and the RBC 2025 Global Healthcare Conference on May 21, 2025 [1][2] - Both events will feature a fireside chat format and 1x1 meetings, with webcasts available for live viewing and replays [2]