CARMEL, Ind., Dec. 15, 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, will present at and participate in the 44th Annual J.P. Morgan Healthcare Conference in San Francisco being held on January 12-15, 2026. 44th Annual J.P. Morgan Healthcare Con ...

Core Insights - MPM BioImpact has divested its entire stake in MBX Biosciences, selling 1,294,416 shares and reducing its exposure by approximately $14.8 million [2][7] - Despite the divestment by MPM, MBX Biosciences has shown strong performance, with its stock price increasing by 71% over the past year, significantly outperforming the S&P 500 [3][4] Company Overview - MBX Biosciences focuses on developing precision peptide therapies for endocrine and metabolic disorders, with key candidates including MBX 2109, MBX 1416, and MBX 4291 [5] - The company operates as a clinical-stage biopharmaceutical entity, aiming to generate value through research, development, and potential commercialization of its drug candidates [5] - As of the latest market close, MBX's stock price is $33.82, with a market capitalization of $1.5 billion and a net income of -$80.5 million over the trailing twelve months [4] Recent Developments - MBX reported positive topline Phase 2 results for canvuparatide in hypoparathyroidism and completed a $200 million upsized offering, ending the quarter with $391.7 million in cash, sufficient to fund operations into 2029 [9] - The CEO emphasized the potential of canvuparatide in a multibillion-dollar market and highlighted upcoming Phase 3 trials and key milestones expected in 2026 [9] - The stock has rebounded sharply after a significant decline post-IPO, reflecting a changed risk profile due to strengthening clinical data and renewed investor interest [6]

Summary of MBX Biosciences Conference Call Company Overview - **Company**: MBX Biosciences - **Focus**: Building a leading biopharmaceutical company focused on endocrine and metabolic diseases with three clinical-stage programs aimed at multi-billion dollar markets [2][44] Key Programs and Developments - **Canvuparatide**: - Recently released outstanding phase two data for a once-weekly PTH replacement therapy in hypoparathyroidism [2] - Anticipated end of phase two meetings with FDA and EMA in Q1 2024 [3] - Phase three registration study initiation expected in Q3 2024 [3] - **MBX 4291**: - A GLP-1 GIP coagonist prodrug with a potential once-monthly dosing schedule for obesity [3][4] - 12-week MAD results expected in Q4 2024, aiming to demonstrate better tolerability and weight loss compared to competitors [5][10] - Unique PK profile with a flat peak-to-trough ratio observed in non-human primate studies, suggesting improved tolerability [9][10] Market Position and Strategy - **Obesity Market**: - The obesity candidate MBX 4291 is positioned to leverage the growing demand for once-monthly dosing in the obesity treatment landscape [4][5] - The company aims to address adherence challenges seen with current incretin therapies, which have high discontinuation rates [17][18] - **Competitive Landscape**: - The company is focused on differentiating its products through better tolerability and convenience, which are critical for chronic use [17][18] - Market research indicates that a well-tolerated drug with comparable weight loss could be considered best in class [18][37] Financial and Operational Outlook - **Funding**: - The company has secured funding into 2029, supporting ongoing clinical trials and pre-commercial activities [3][46] - **Regulatory Strategy**: - Plans to engage with regulatory agencies to discuss trial designs and endpoints, including stratification for PTH levels and urine calcium changes [31][32] Other Programs - **Imapextide and PBH Program**: - Phase two study focusing on pharmacodynamic effects, aiming to increase glucose nadir while reducing insulin peak [40] - Safety profile indicates benign nature of injection site reactions, which are not expected to impede prescribing if approved [41][42] Underappreciated Aspects - **Platform Technology**: - The potential of MBX's clinically proven platform technology for gradual controlled release is highlighted as a key differentiator [44][46] - **Pipeline Value**: - The company emphasizes the value inflection points across its pipeline programs, positioning itself favorably in the market [46] Conclusion - MBX Biosciences is poised for significant developments in 2024, with multiple catalysts expected across its pipeline, particularly in obesity and endocrine therapies. The focus on tolerability and convenience in drug administration is central to its strategy in a competitive market.

Core Insights - MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing precision peptide therapies for endocrine and metabolic disorders [1][3] - The company will present at the 37th Annual Piper Sandler Healthcare Conference on December 2-4, 2025 [1][2] Company Overview - MBX Biosciences utilizes its proprietary PEP™ platform to discover and develop novel peptide therapies [3] - The company has a pipeline that includes canvuparatide (MBX 2109) for chronic hypoparathyroidism and imapextide (1416) for post-bariatric hypoglycemia, both in Phase 2 development [3] - An obesity portfolio is also in development, including MBX 4291 in Phase 1 and several pre-clinical candidates [3] - The company is based in Carmel, Indiana [3]

Summary of MBX Biosciences Conference Call Company Overview - **Company**: MBX Biosciences (NasdaqGS:MBX) - **Focus**: Development of precision endocrine peptides for endocrine and metabolic disorders, with three clinical programs targeting hypoparathyroidism, post-bariatric hypoglycemia (PBH), and obesity [1][2] Key Points and Arguments Clinical Programs - **Pipeline**: Three clinical-stage programs with potential best-in-class profiles aimed at multibillion-dollar markets [2] - **Technology**: Precision endocrine peptide (PEP) technology is clinically validated, providing consistent drug exposure and convenient dosing regimens [2] - **Financial Position**: Strong financial position with cash reserves projected to last until 2029 following a follow-on raise in September [3] Upcoming Catalysts - **Canvuparatide**: - A PTH replacement therapy prodrug with an end-of-phase 2 meeting planned for Q1 2026 [3] - Full data presentation at a major medical meeting in Q2 2026, followed by a phase 3 global registration study initiation in Q3 2026 [3][4] - Phase 2 AVAIL study showed a 63% responder rate at 12 weeks, increasing to 79% at six months [5][6] - Positive feedback from key opinion leaders (KOLs) and patients regarding the once-weekly administration [8][9] - **MBX 4291**: - A once-monthly GLP-1/GIP co-agonist prodrug with 12-week data expected in Q4 2026 [3][4] - Aimed at addressing the unmet need in the PBH market, which has an estimated prevalence of over 125,000 in the US [20][22] Market Insights - **PBH Market**: Significant unmet need with no approved pharmacotherapy, leading to lifestyle changes for patients [20] - **Obesity Landscape**: The company is developing a GLP-1/GIP co-agonist, differentiating itself from competitors by offering a prodrug formulation that allows for once-monthly dosing with better tolerability [28][30] Competitive Landscape - **Differentiation**: MBX's approach focuses on a dual agonist mechanism (GLP-1/GIP) rather than a monoagonist, which is seen as the gold standard in obesity treatment [42][43] - **Market Research**: Positive market research feedback indicates a preference for MBX's once-weekly dosing over existing once-daily therapies [8][9] Future Directions - **Phase 3 Study Goals**: Aiming for competitive treatment response and safety profile, with a focus on urine calcium as a potential label indication [13][15] - **Partnership Opportunities**: Potential for strategic partnerships in the future, especially for longer-term studies and general practice indications [48][49] Additional Important Insights - **Patient Feedback**: High patient interest in weekly administration for hypoparathyroidism treatment, with anecdotal evidence of improved quality of life [10][11] - **Manufacturing Advances**: Continuous improvements in peptide synthesis are expected to reduce costs over time [46] This summary encapsulates the key points discussed during the MBX Biosciences conference call, highlighting the company's strategic direction, clinical advancements, and market positioning.

Core Insights - MBX Biosciences reported positive topline results from the Phase 2 Avail™ trial of once-weekly canvuparatide for hypoparathyroidism, indicating potential best-in-class status in a multibillion-dollar market [2][3] - The company completed an upsized public offering, raising approximately $200 million in gross proceeds, which is expected to support operations into 2029 [1][5] - Updated corporate milestones for 2026 include clinical data for three Precision Endocrine Peptide™ (PEP) programs and the initiation of a Phase 3 trial in hypoparathyroidism [1][2] Clinical Developments - Canvuparatide achieved the primary composite endpoint in the Phase 2 Avail™ trial, with 63% of treated patients achieving responder status at 12 weeks and 79% at six months in the ongoing open-label extension study [3][4] - The company plans to conduct an End of Phase 2 meeting with the U.S. FDA and seek Scientific Advice from the European Medicines Agency in Q1 2026 [3] - The first participant has been dosed in the Phase 1 trial of MBX 4291 for obesity, which is designed to evaluate safety, tolerability, and pharmacokinetics [3][4] Financial Performance - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $391.7 million, an increase from $262.1 million at the end of 2024 [9][16] - Research and development expenses for Q3 2025 were $19.3 million, up from $16.7 million in Q3 2024, driven by ongoing clinical trials [9][16] - The net loss for Q3 2025 was $21.6 million, compared to a net loss of $18.1 million for the same period in 2024 [9][16] Corporate Governance - Steve Hoerter was appointed as executive chairperson to support the executive team with commercialization experience as the company prepares for the Phase 3 trial [2] - Jim Cornelius retired from the board after over five years of service [2]

Core Insights - MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing precision peptide therapies for endocrine and metabolic disorders [4] Upcoming Investor Conferences - The company will participate in several investor conferences, including: - Guggenheim 2nd Annual Healthcare Innovation Conference on November 10, 2025, in Boston, MA [2] - Stifel Healthcare Conference on November 12, 2025, in New York, NY [2] - Jefferies Global Healthcare Conference on November 19, 2025, in London, UK [2] - TD Cowen Treatment Advancements in Obesity and Related Disorders Summit on November 24, 2025, virtually [3] Company Pipeline - MBX Biosciences is advancing a pipeline that includes: - Canvuparatide (MBX 2109) for chronic hypoparathyroidism, preparing for Phase 3 development [4] - Imapextide (1416) for post-bariatric hypoglycemia, currently in Phase 2 development [4] - An obesity portfolio including MBX 4291 in Phase 1 development and multiple discovery and pre-clinical candidates [4]

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.

Core Insights - MBX Biosciences, Inc. is participating in the Stifel 2025 Virtual Cardiometabolic Forum, highlighting its focus on precision peptide therapies for endocrine and metabolic disorders [1][2] Company Overview - MBX Biosciences is a clinical-stage biopharmaceutical company based in Carmel, Indiana, specializing in the discovery and development of novel precision peptide therapies using its proprietary PEP™ platform [3] - The company is advancing a pipeline that includes canvuparatide (MBX 2109) for chronic hypoparathyroidism and imapextide (1416) for post-bariatric hypoglycemia, both in Phase 2 development [3] - Additionally, MBX has an obesity portfolio that includes MBX 4291 in Phase 1 development and multiple discovery and pre-clinical candidates [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]