UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-42272 MBX Biosciences, Inc. (Exact Name of Registrant as Specified in its Charter) (317) 659-0 ...

Exhibit 99.1 MBX Biosciences Reports Second Quarter 2025 Financial Results and Recent Corporate Highlights Topline results for the Phase 2 Avail™ trial of canvuparatide in hypoparathyroidism on track for Q3 2025 Imapextide (MBX 1416) Phase 2a trial initiation in patients with post-bariatric hypoglycemia anticipated in Q3 2025 MBX 4291 Phase 1 trial initiation in obesity anticipated in Q3 2025 $224.9 million in cash, cash equivalents and marketable securities as of June 30, 2025; expected to support operatio ...

Core Insights - Microbix Biosystems Inc. will present its H5N1 pandemic preparedness results at the ADLM conference in Chicago from July 28 to 31, 2025 [1][2] - The company will showcase its quality assessment products (QAPs™) that ensure the accuracy of antigen and molecular tests [2][3] - A pilot External Quality Assessment (EQA) program will be presented, focusing on the detection of the H5N1 strain using existing molecular tests [3][4] Company Overview - Microbix is a life sciences innovator with over 120 employees and aims for revenues of C$ 2.0 million or more per month [6] - The company specializes in proprietary biological products for human health, including antigens for immunoassays and QAPs that support clinical lab proficiency testing [6][7] - Microbix's QAPs are available in over 30 countries and are supported by a network of international distributors [6] Product Development - The H5N1 QAPs were developed to ensure full genetic coverage of potential pandemic strains and are available in liquid and FLOQSwab formats [5] - The collaboration with American Proficiency Institute (API) is crucial for evaluating the performance of flu tests in detecting H5N1 [4][5] - The company emphasizes the rapid deployment of its capabilities in response to emerging pandemics [5]

Microbix to Develop New Products using NCIPD Organism CollectionMISSISSAUGA, Ontario and SOFIA, Bulgaria, July 08, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, and the National Center for Infectious and Parasitic Diseases of Bulgaria (“NCIPD”), announce an agreement whereby NCIPD will supply a portfolio of pathogen seedstocks for production of Microbix quality assessment products (“QAPs™”). Following detailed di ...

Core Insights - Microbix Biosystems Inc. is participating in the 2nd Asia Pacific Conference on Point of Care Testing for Infectious Diseases in Bangkok, showcasing its quality assessment products (QAPs) for point-of-care testing [1][2] Group 1: Conference Participation and Presentation - The conference aims to enhance access to rapid diagnostic tools for infectious diseases and features innovations in point-of-care testing [2] - Microbix will present a poster titled "Addressing QC Challenges in Point-of-Care Infectious Disease Testing," highlighting the use of nearly 60,000 QAPs supporting SARS-CoV-2 tests over three years [3] Group 2: Product and Market Impact - Microbix's QAPs have demonstrated reliable quality management system support across diverse usage settings, contributing to its selection as a key quality control device for the EPICC partnership aimed at HPV elimination in the Indo-Pacific [3] - The company is targeting revenues of C$ 2.0 million or more per month and has a presence in over 30 countries through international distributors [5] Group 3: Future Business Development - Discussions with diagnostics program managers and manufacturers are scheduled at the conference to expand Microbix's role in more point-of-care testing programs [4] - Microbix's QAPs are essential for clinical lab proficiency testing and are sold to various stakeholders in the diagnostics industry [5]

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]

Summary of MBX Biosciences FY Conference Call Company Overview - **Company**: MBX Biosciences - **Industry**: Clinical stage biopharmaceuticals focused on peptide therapeutics - **Key Focus**: Development of innovative peptide-based therapies for chronic hyperparathyroidism (HP), post-bariatric hypoglycemia (PBH), and obesity [2][3] Core Points and Arguments - **Significant Year Ahead**: 2025 is projected to be a pivotal year with the upcoming release of AVAIL Phase II data for the first PTH replacement therapy prodrug, Canbuparatide [2] - **PEP Technology**: MBX utilizes a proprietary PEP technology to create therapies with continuous infusion-like pharmacokinetics (PK) and infrequent dosing regimens [3][4] - **Pipeline**: - **Canbuparatide**: A potential once-weekly PTH replacement therapy with orphan drug designation in the US, currently in Phase II trials [5][11] - **MBX1416**: A potential once-weekly therapy for PBH, with plans for Phase II trials following positive Phase I results [5][21] - **Obesity Portfolio**: Includes MBX4291, a GLP-1 GIP coagonist prodrug aimed at once-monthly dosing [6][29] Financial Position - **Funding**: MBX ended the last quarter with over $240 million, expected to support operations into mid-2027 [4] Clinical Development Highlights - **Canbuparatide**: - Phase I results showed favorable safety and tolerability, with a flat infusion-like PK profile [13][14] - Phase II trial fully enrolled with 64 patients, aiming for a statistically significant treatment effect [15][17] - **MBX1416**: - Designed to be the first approved once-weekly treatment for PBH, with a favorable safety profile demonstrated in Phase I studies [21][22] - **MBX4291**: - Expected to file an IND this quarter, with a Phase I study planned to demonstrate once-monthly dosing and improved tolerability [29] Market Opportunities - **Chronic Hyperparathyroidism**: Affects over 250,000 people in the US and EU, with current treatments inadequate [10] - **Post-Bariatric Hypoglycemia**: Estimated prevalence over 90,000 in the US, with no approved pharmacotherapy available [18][20] - **Obesity**: Recognized as a global epidemic, with MBX aiming to address the heterogeneous needs of this population through innovative therapies [23][24] Unique Selling Proposition - **Differentiated PK Profile**: MBX's therapies aim to reduce side effects associated with rapid concentration peaks seen in current treatments, potentially leading to better patient adherence and outcomes [25][27] Conclusion - MBX Biosciences is positioned to make significant advancements in the treatment of chronic HP, PBH, and obesity through its innovative peptide technologies and well-funded pipeline, with multiple near-term milestones expected to create value [30]

Summary of MBX Biosciences Conference Call Company Overview - **Company**: MBX Biosciences - **Industry**: Biotechnology - **Focus**: Development of peptide therapeutics for chronic hypoparathyroidism (HP) and post-bariatric hypoglycemia (PBH) [2][3] Key Points Upcoming Milestones - **Phase II Data Release**: Expected in Q3 2025 for AVAIL study, which is the first once-weekly PTH replacement therapy for chronic HP [2][6] - **Pipeline Development**: MBX has multiple clinical programs targeting significant unmet needs, including obesity [3][5] Product Candidates - **Lead Candidate**: Canvoparatide, a once-weekly PTH replacement therapy for chronic HP, with a U.S. prevalence of over 250,000 patients [5][6] - **Second Candidate**: MBX1416 for PBH, with an estimated U.S. prevalence of over 90,000 patients [7][8] - **Obesity Portfolio**: Includes NBX4291, a GLP-1 GIP co-agonist prodrug, with an IND filing expected in Q2 2025 [9][76] Clinical Trial Insights - **AVEIL Study Design**: 64 patients randomized to receive either canvoparatide or placebo, with a primary endpoint of treatment response defined as independence from active vitamin D while maintaining normal serum calcium levels [19][20] - **Expected Outcomes**: Aiming for a 55% responder rate in the treatment group compared to 7% in the placebo group, indicating a placebo-adjusted treatment response of approximately 48% [20][28] Safety and Efficacy - **Safety Monitoring**: Focus on hypo- and hypercalcemia excursions, with expectations of fewer excursions due to the drug's pharmacokinetic profile [51][52] - **Phase I Results**: Positive outcomes in healthy volunteers, with expected differences in response for HP patients due to their PTH deficiency [53][55] Competitive Landscape - **Comparison with Competitors**: Canvoparatide's 12-week results will be compared to Ascendis' Yorvy Pass, which showed a 64% response rate at 6 months [22][28] - **Differentiation Strategy**: Emphasis on the unique infusion-like pharmacokinetics and the potential for better tolerability in comparison to existing therapies [77][79] Financial Position - **Funding Status**: MBX is well-funded, with cash reserves to support operations until mid-2027, allowing for the advancement of multiple programs [4] Additional Insights - **Regulatory Pathway**: Plans to conduct an end-of-phase II meeting followed by a phase III trial based on the upcoming Phase II results [70] - **Market Potential**: The company believes its products have blockbuster revenue potential due to the significant unmet medical needs in the targeted conditions [5][6] This summary encapsulates the critical aspects of MBX Biosciences' conference call, highlighting the company's strategic direction, product pipeline, and anticipated clinical milestones.

Group 1 - The article discusses the importance of staying updated on stocks in the biotech, pharma, and healthcare industries, particularly focusing on glucagon-like peptide receptor agonists (GLP-RA or GLP-1s) [1] - It highlights the services provided by the Haggerston BioHealth investing group, which includes catalysts for investment decisions, sales forecasts, and financial analyses for major pharmaceutical companies [1] - The author, Edmund Ingham, has extensive experience in biotech consulting and has produced detailed reports on over 1,000 companies in the sector [1]

Summary of MBX Biosciences Conference Call Company Overview - **Company**: MBX Biosciences - **Industry**: Clinical stage biopharmaceuticals focusing on peptide technology - **Key Technology**: Precision Endocrine Peptide (PEP) technology platform aimed at optimizing peptide therapies for endocrine diseases [3][4] Core Points and Arguments - **Financial Position**: MBX has $2.24 billion in funding as of the last quarter, expected to support operations until mid-2027 [4][5] - **Lead Indication**: Focus on chronic hypoparathyroidism (HP), affecting over 250,000 people in the US and EU [7] - **Current Treatment Landscape**: Standard care involves high doses of vitamin D and calcium supplements, which do not address the underlying PTH deficiency [8][9] - **New Therapy**: Camboparatide (CANVU) is a once-weekly PTH replacement therapy designed to improve patient convenience and outcomes compared to existing treatments [10][21] - **Phase One Data**: Positive results showing dose-dependent increases in serum calcium and a long half-life of 8-9 days, supporting once-weekly dosing [14][16] - **Phase Two Trial Design**: A 12-week trial with a fixed dose period followed by dose adjustments, aiming for a statistically significant treatment response rate of at least 55% [19][21] Competitive Landscape - **Market Entry**: The launch of Yorvy Path, a once-daily PTH replacement therapy, is seen as a positive development, with initial sales of approximately $50 million [26] - **Patient Demand**: There is significant demand for PTH replacement therapy among HP patients, who often feel inadequately managed on current supplements [27][28] Other Pipeline Programs - **Post-Bariatric Hypoglycemia (PBH)**: MBX is developing a long-acting GLP-1 antagonist for PBH, a condition with no approved pharmacotherapy, targeting a market comparable in size to HP [30][31] - **Obesity Program**: A new obesity treatment (4291) is in development, aiming for once-monthly dosing and improved tolerability compared to existing therapies like tirzepatide [38][40] Additional Insights - **Patient-Centric Approach**: The company emphasizes patient needs and aims to provide more effective treatment options [26][27] - **Regulatory Progress**: Plans to file an IND for the obesity program within the current quarter [43] - **Future Milestones**: The upcoming phase two results for CANVU are viewed as a transformative milestone for both the company and the field of HP treatment [24][44]