MBX Biosciences FY Conference Summary Company Overview - **Company**: MBX Biosciences (NasdaqGS:MBX) - **Focus**: Pioneering Precision Endocrine Peptides (PEPs) for treating endocrine and metabolic disorders [1][4] Key Updates and Expectations for 2026 - **Pivotal Year**: 2026 is expected to be crucial with significant milestones across three clinical stage programs and advancements in obesity discovery and preclinical development [1] - **Cash Runway**: The company has a cash runway extending into 2029, providing flexibility in advancing its pipeline [3] Clinical Programs Canvuparatide - **Phase II Meeting**: An end-of-phase II meeting with the FDA is scheduled, with updates on study design for phase III expected [2] - **Phase II Update**: One-year data will be released in Q2, with a global registrational phase III study initiation planned for Q3 [2] - **Response Rate**: A 63% response rate was observed in a 12-week placebo-controlled study, with 79% of patients responding during the open-label extension [9][10] Obesity Portfolio - **MBX-4291**: A once-monthly GLP-1/GIP co-agonist with anticipated 12-week data from a multiple ascending dose study [2] - **New Candidates**: Two additional candidate selections targeting amylin and glucagon are expected in Q2 and Q3 [2] Imapextide - **Phase IIa Study**: A pharmacodynamic study is underway for post-bariatric hypoglycemia, with results expected in Q2 2024 [24][25] Technology and Differentiation - **PEP Technology**: The proprietary PEP technology allows for slow release and steady exposure, improving tolerability and reducing side effects associated with traditional therapies [4][19] - **Best-in-Class Potential**: The company aims to develop best-in-class drugs, with positive feedback from the physician community regarding their clinical data [12][15] Market Opportunity - **Hypoparathyroidism**: The disease has a prevalence of over 250,000 in the US and EU, with current treatments being inadequate [7] - **Obesity Treatment**: The company recognizes obesity as a heterogeneous disease requiring diverse therapeutic options, with a focus on improving tolerability and adherence [18] Financial Position - **Cash Balance**: Year-end cash balance of $373 million, projected to increase to $460 million post recent stock sale, supporting operations through 2029 [34][35] - **Commercialization Plans**: Preparations for the commercialization of canagliflozin are underway, with a focus on recruiting a Chief Commercial Officer [36] Conclusion - **Growth Potential**: MBX Biosciences is positioned for a catalyst-rich year with multiple data releases and a strong pipeline aimed at addressing significant health issues in endocrine and metabolic disorders [33][36]

CARMEL, Ind., Feb. 23, 2026 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization 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 participate in the following upcoming March investor conferences: Citizens Life Sciences Conference Date ...

Core Viewpoint - Microbix Biosystems Inc. reported Q1 revenues of $4.2 million, indicating a recovery in revenue growth following previous client setbacks [1] Financial Performance - The company achieved a revenue growth of 13% compared to Q4 fiscal 2025, demonstrating efforts to rebuild revenues above the breakeven point [1] - The controlled net loss indicates improved financial management and operational efficiency [1]

Core Insights - MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on precision peptide therapies for endocrine and metabolic disorders [1][3] - The company will participate in two upcoming investor conferences, providing opportunities for engagement with investors [2] Company Overview - MBX Biosciences specializes in the discovery, development, and commercialization 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, which is preparing for Phase 3 development [3] - The obesity portfolio includes MBX 4291 in Phase 1 development and several discovery and pre-clinical candidates [3] - Imapextide (MBX 1416) is in Phase 2 development for post-bariatric hypoglycemia [3] - The company is based in Carmel, Indiana [3]

Core Viewpoint - Microbix Biosystems Inc. is presenting its novel Quality Assessment Products and platform technology aimed at enhancing quality management and reproducibility in Molecular Pathology diagnostics at an upcoming lab diagnostics conference in Helsinki, Finland [1] Group 1: Company Overview - Microbix Biosystems Inc. is identified as a life sciences innovator, manufacturer, and exporter [1] Group 2: Industry Context - The presentation focuses on Molecular Pathology, which combines traditional pathology with nucleic acid analysis for diagnosing infectious diseases [1]

Core Insights - MBX Biosciences, Inc. has appointed Laurie Stelzer as an independent director and chairperson of the audit committee, bringing extensive executive and financial leadership experience [1][2] - The company is focused on developing precision peptide therapies for endocrine and metabolic disorders, with a strong pipeline and a catalyst-rich year ahead [2][3] Company Overview - MBX Biosciences specializes in the discovery, development, and commercialization 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, an obesity portfolio with MBX 4291 in Phase 1, and imapextide (MBX 1416) for post-bariatric hypoglycemia in Phase 2 [3] Leadership and Governance - Laurie Stelzer has over 25 years of experience in finance and leadership roles across various biopharmaceutical companies, including previous positions as CFO at multiple firms [2] - Stelzer's expertise is expected to enhance the company's governance and strategic direction as it progresses through clinical trials [2]

Company Overview - MBX is an Indiana-based company participating in the 44th Annual Healthcare Conference hosted by JPMorgan [1] - The company is led by CEO Kent Hawryluk, who expressed gratitude for the opportunity to present for the fourth consecutive year [2] Key Personnel - Richard DiMarchi, a distinguished Professor of Biochemistry at Indiana University and inventor of significant medical advancements, was highlighted as a VIP guest [2] - DiMarchi's contributions include the development of Humalog and the first GLP-1/GIP co-agonist, which are crucial for treating metabolic diseases [2] Industry Impact - The innovations associated with Richard DiMarchi have positively affected millions of patients suffering from metabolic diseases, underscoring the importance of research and development in the biotech sector [2]

Summary of MBX Conference Call Company Overview - **Company**: MBX - **Industry**: Biotechnology, focusing on endocrine and metabolic diseases - **Key Product**: Canvaparatide, a treatment for hypoparathyroidism and obesity Core Points and Arguments 1. **Leadership and Innovation**: MBX is led by CEO Kent Hawryluk and co-founder Richard DiMarchi, who has a significant history in biochemistry and drug development, particularly in metabolic diseases [2][3] 2. **Pipeline and Milestones**: - Canvaparatide is the lead program with a confirmatory phase 3 trial set to begin in Q3 2023, following successful phase 2 data [4] - The company is expanding its obesity portfolio, including MBX 4291, a GLP-1/GIP co-agonist with potential for once-monthly dosing [4][5] - Upcoming data releases include 12-week results from a phase 1 study and phase 2 A proof of concept for imipexide [4][5] 3. **Financial Position**: MBX has approximately $375 million in cash following a $200 million public offering, which supports ongoing clinical studies [5] 4. **PEP Technology**: The precision endocrine peptide (PEP) platform is designed to optimize drug properties for better patient experience, including tolerability and dosing frequency [5][6] 5. **Market Opportunity**: - The U.S. and E.U. prevalence of hypoparathyroidism is estimated at over 250,000, with a significant unmet need for effective treatments [8] - New treatment guidelines emphasize the importance of PTH replacement therapies, positioning MBX favorably against competitors like YorviPath [8][9] 6. **Clinical Data**: - The AVAIL phase 2 study showed a 63% responder rate at 12 weeks, improving to 79% at six months, with high patient retention in the open-label extension [9][34] - Safety and tolerability were strong, with no treatment-related serious adverse events reported [9] 7. **Patient Preference**: Market research indicates that 100% of patients prefer once-weekly dosing over daily dosing, which aligns with MBX's product offerings [10][11] 8. **Obesity Treatment Landscape**: The company aims to address the full spectrum of obesity treatment needs, focusing on tolerability and dosing frequency as key differentiators [12][15] Additional Important Content 1. **Regulatory Strategy**: MBX plans to meet with the FDA for an end-of-phase two meeting to discuss trial design and endpoints for the phase 3 program [42][43] 2. **Market Dynamics**: Despite the presence of competitors, MBX believes there is a significant market share available for PTH replacement therapies, particularly with the unique attributes of Canvaparatide [50] 3. **Patient Engagement**: Anecdotal evidence from patient associations indicates strong enthusiasm for the potential of weekly administration therapies, which could enhance recruitment for clinical trials [46][48] 4. **Long-term Vision**: MBX aims to become a leader in the obesity field, with a focus on innovative therapies that cater to individual patient needs [12][56] This summary encapsulates the key points discussed during the MBX conference call, highlighting the company's strategic direction, product pipeline, and market positioning within the biotechnology industry.

Financial Position - As of December 31, 2025, MBX Biosciences reported unaudited cash, cash equivalents, and marketable securities of $373.7 million, expected to fund operations into 2029[6]. - The company estimates that its current cash resources may be exhausted sooner than expected due to underlying assumptions[10]. Business Development - The company plans to expand its obesity portfolio in 2026 with two additional obesity candidates, with nominations anticipated in Q2 and Q3 2026[9]. - Forward-looking statements include expectations regarding the timing of additional obesity candidates and financial results, which are subject to risks and uncertainties[11]. Audit and Compliance - The ongoing audit of the consolidated financial statements for the year ended December 31, 2025, may result in changes to the reported financial information[6]. - The financial results will be reflected in the audited consolidated financial statements for the fiscal year ended December 31, 2025[12]. - The company has not elected to use the extended transition period for complying with new financial accounting standards[5]. Risks - Risks include the company's reliance on third parties for clinical trials and product development, as well as the need for substantial additional funds for commercialization[12]. Company Classification - The company is classified as an emerging growth company under the Securities Act of 1933[5]. Press Release - The press release regarding the 2026 outlook and business update was issued on January 11, 2026[7].

Core Insights - MBX Biosciences is advancing its clinical programs, particularly focusing on canvuparatide for chronic hypoparathyroidism and MBX 4291 for obesity, with significant milestones expected in 2026 [2][4] Group 1: Clinical Development - The Phase 2 trial of canvuparatide has shown strong proof-of-concept with high responder rates and is preparing for a pivotal Phase 3 trial set to initiate in Q3 2026 [4] - One-year follow-up data from the Phase 2 trial of canvuparatide is anticipated in Q2 2026, which will provide further insights into its efficacy [1] - MBX 4291, a dual GLP-1/GIP co-agonist prodrug, is progressing through Phase 1 evaluation, with 12-week data expected in Q4 2026 [1][4] Group 2: Pipeline Expansion - The company plans to nominate two additional obesity candidates in 2026, including an amycretin prodrug and a GLP-1/GIP/GCGR triple agonist, both designed for once-monthly dosing [1][4] - Results from the ongoing Phase 2a STEADI™ trial of imapextide are expected in Q2 2026, focusing on post-prandial glucose regulation [4] Group 3: Financial Position - As of December 31, 2025, MBX Biosciences reported a preliminary unaudited cash position of approximately $373.7 million, which is expected to fund operations into 2029 [5][6] - The strong cash position allows the company to continue investing in long-term pipeline growth and execute its strategic plans effectively [2]