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 ...

Summary of MBX Biosciences Conference Call Company Overview - **Company**: MBX Biosciences - **Industry**: Biopharmaceuticals, focusing on peptide drug design and development - **Key Products**: - Kaniparutide for hypoparathyroidism - MBX 1416, a GLP-1 antagonist for post-bariatric hypoglycemia - MBX 4291, a dual agonist for obesity Core Points and Arguments - **Kaniparutide**: - Positive Phase 2 results with a 79% responder rate at six months, up from 63% at 12 weeks [3] - Comparison with a once-daily injectable that has a 69% responder rate at six months [3] - 94% of trial participants chose to enroll in a two-year open-label extension study, indicating strong patient interest [4] - No treatment-related serious adverse events (SAEs) reported, highlighting safety and tolerability [4] - Positioned to establish a new standard of care in adults with hypoparathyroidism as it advances to Phase 3 registration study [4] - **MBX 1416**: - A potential first-in-class treatment for post-bariatric hypoglycemia (PBH) [4] - Currently in Phase 2a study, addressing a significant unmet need as there are no approved pharmacotherapies for PBH [19] - Mechanism of action involves GLP-1 antagonism, which is clinically validated [19] - Demonstrated a half-life of 90 hours, significantly longer than existing treatments [19] - **MBX 4291**: - An ultra-long-acting GLP-1/GIP co-agonist prodrug with potential for once-monthly dosing [5] - Aims for improved gastrointestinal tolerability and greater weight loss compared to current products [5] - Preclinical studies show superior pharmacokinetic profiles compared to tirzepatide, with a gradual controlled release [8] - Expected to enter Phase 1 study in high BMI adults, focusing on tolerability and weight loss [10] Financial Position - As of June 30, 2025, the company has approximately $412 million in cash, extending its operating runway into 2029 [5] - This financial strength supports the advancement of key milestones across its pipeline, including the Phase 3 study for Kaniparutide [5] Additional Insights - **Durability of Effect**: The prodrug design aims to improve patient adherence and reduce discontinuations, which is critical for obesity treatments [12] - **Market Landscape**: The company is aware of the competitive nature of the obesity field and is exploring various validated targets, including glucagon and amylin [16] - **Partnership Strategy**: The company plans to partner its obesity programs strategically, given the large registration studies and sales forces required [17] - **Regulatory Pathway**: The company is preparing for an end-of-Phase 2 meeting with the FDA to align on the Phase 3 registration study design for Kaniparutide [38] Conclusion MBX Biosciences is positioned as a transformative player in the biopharmaceutical industry, particularly in the areas of hypoparathyroidism and obesity, with promising clinical data and a strong financial foundation to support its innovative pipeline. The focus on patient adherence and tolerability, along with strategic partnerships, will be crucial for its success in a competitive market.

CARMEL, Ind., Sept. 29, 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, MD, Chief Medical Officer, will participate in a fireside chat at the Stifel 2025 Virtual Cardiometabolic Forum on September 30. Stifel 2025 Virtual Cardiome ...

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 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]