Topline results for the Phase 2 Avail™ evaluating canvuparatide in patients with hypoparathyroidism expected in 3Q 2025 Investigational New Drug submission for MBX 4291 on track for 2Q 2025 $240.8 million in cash, cash equivalents and marketable securities as of March 31, 2025; expected to support operations into mid-2027 CARMEL, Ind., May 12, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision p ...

Results Release and Webinar Discussion on Morning of May 15, 2025MISSISSAUGA, Ontario, May 08, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it expects to file the financial statements, management disclosure and analysis, and results news release for its second quarter of fiscal 2025 ended March 31, 2025 (“Q2 2025”) prior to the start of trading on May 15, 2025. At 11:00 AM ET on that day, Microbix ...

Summary of MBX Biosciences Conference Call Company Overview - **Company**: MBX Biosciences - **Type**: Public clinical stage biopharmaceutical company - **CEO**: Kent Harlock - **Focus**: Development of peptide therapeutics using the precision endocrine peptide (PEP) platform technology [3][4] Industry Context - **Sector**: Biotechnology - **Recent Activity**: Recent IPO in the biotech space, with a focus on rare endocrine diseases and obesity treatments [1][3] Key Points and Arguments Pipeline and Product Candidates - **Clinical Programs**: Two clinical stage programs with a third expected soon, targeting significant unmet needs in rare endocrine diseases: - Hypoparathyroidism (HP) - Post-bariatric hypoglycemia (PBH) - Obesity treatments [5][6] - **Revenue Potential**: Estimated over $1 billion in revenue for each rare disease program, with considerable upside for the obesity portfolio [5][6] - **Lead Drug**: Campuperatide, a potential first once-weekly PTH replacement therapy, has orphan drug designation in the US and positive phase one results [6][9] - **Second Compound**: NBX1416, a long-acting GLP-1 antagonist for PBH, with plans to advance to phase two trials [7][39] Clinical Trial Insights - **Phase II Trial for HP**: Fully enrolled with 64 patients, designed to support dose selection for phase three and provide comprehensive data for comparison with peers [13][29] - **Primary Endpoint**: Proportion of patients eliminating active vitamin D supplements while maintaining normal serum calcium levels, aiming for a 50% placebo-adjusted treatment response [27][30] - **Phase II for PBH**: Expected to begin in the second half of the year, with a focus on optimizing dosing based on previous studies [40][43] Competitive Landscape - **Standard of Care**: Current treatments for HP are inadequate, leading to fluctuations in serum calcium levels and adverse effects. MBX aims to provide a superior alternative with its once-weekly dosing [9][12][18] - **Comparison with Competitors**: MBX's products are designed to have a more stable pharmacokinetic profile compared to existing therapies, which may lead to better patient adherence and outcomes [12][24][39] Financial Position - **Funding**: Strong financial position with cash to support operations into mid-2027, allowing for multiple value-creating milestones [5][6] Future Outlook - **Market Potential**: Significant unmet needs in both HP and PBH, with no approved pharmacotherapy for PBH, indicating a strong market opportunity for MBX's products [38] - **Obesity Focus**: Anticipation of additional obesity candidates in the future, leveraging the PEP platform technology [51][52] Additional Important Insights - **Patient Experience**: Current standard of care for HP requires inconvenient dosing regimens, highlighting the need for more patient-friendly options [18][19] - **Regulatory Considerations**: Engagement with the FDA to optimize study designs and claims for product labeling [22][24] - **Long-term Vision**: MBX aims to establish itself as a leader in peptide therapeutics, with a focus on continuous innovation and addressing chronic diseases [49][50] This summary encapsulates the key points discussed during the conference call, highlighting MBX Biosciences' strategic direction, product pipeline, and market opportunities.

Sequel Pharma Executes Agreement with CDMO for Drug Product ManufacturingMISSISSAUGA, Ontario, May 05, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that its funding and commercialization partner, Sequel Pharma, LLC (“Sequel”), has executed an agreement with a leading international contract development and manufacturing organization (“CDMO”) for production of the formulated and packaged drug (i.e., “Dru ...

MISSISSAUGA, Ontario, May 01, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces it will be attending and presenting at the 2025 Bloom Burton & Co. Healthcare Investor Conference (the “Conference”) taking place at the Metro Toronto Convention Centre, North Building, on Monday and Tuesday, May 5 & 6, 2025. The Conference provides Microbix the opportunity to build connections with Canadian, U.S., and internati ...

MISSISSAUGA, Ontario, April 09, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix), a life sciences innovator, manufacturer, and exporter, announces that it will be attending and exhibiting at ESCMID Global 2025 and that a customer and collaborator will be presenting results of a pilot External Quality Assessment (EQA) program enabled by Microbix Quality Assessment Products (QAPs™). ESCMID Global is the Congress of the European Society of Clinical Microbiology and Infectiou ...

Core Viewpoint - Microbix Biosystems Inc. is positioned favorably in the current tariff landscape, with no tariffs applicable to its products sold in the U.S. under the USMCA trade agreement, providing a competitive advantage over other exporting economies facing significant tariffs [2][3] Group 1: Tariff Implications - The U.S. government has imposed tariffs on certain goods imported from Canada, but Microbix's products remain exempt, enhancing its competitive position [2] - Microbix is concerned about potential reciprocal tariffs from Canada on U.S.-made life sciences equipment and consumables, as it purchases approximately C$ 1.5 million in equipment and over C$ 4.0 million in consumables annually [3] Group 2: Sales Outlook - The outlook for sales of QAPs™ remains positive, with expected strong growth across its three segments: lab proficiency-testing agencies, test-makers, and clinical labs [4] - Sales of test-ingredients (Antigens) have become less favorable, particularly due to halted sales in China attributed to a light burden of respiratory infectious diseases during the 2025 Chinese New Year, affecting replenishment needs [5] Group 3: Business Development - Microbix is expanding its capabilities and capacity through new projects and collaborations, including support for diagnostics test programs and entry into molecular pathology, oncology, and genetics tests [6] - The company maintains a strong financial position, with over C$ 14 million in cash and equivalents as of March 2025, following the repayment of mortgage debt and ongoing share repurchases [7] Group 4: Company Overview - Microbix Biosystems Inc. specializes in proprietary biological products for human health, targeting sales of C$ 2.0 million or more per month, and exports critical ingredients for the global diagnostics industry [8] - The company is ISO 9001 & 13485 accredited and registered with U.S. FDA, Australian TGA, and Health Canada, ensuring compliance with international standards [8]

CARMEL, Ind., April 07, 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 the appointment of Steve Hoerter as an independent director to the Company's Board of Directors. Mr. Hoerter brings over three decades of pharmaceutical commercialization and executive leadership experience as well as a proven track r ...

MISSISSAUGA, Ontario, March 27, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQB: MBXBF) ("Microbix®" or the "Company"), a life sciences innovator and exporter, announces the voting results from the Annual and Special Meeting of Shareholders of the Company (the "Meeting") which was held on March 26, 2025. At the Meeting, 42.83% of the issued and outstanding shares were represented. Shareholders voted in favour of all resolutions brought before the Meeting. Details of all resolutions that w ...

CARMEL, Ind., March 26, 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 24th Annual Needham Virtual Healthcare Conference. 24th Annual Needham Virtual Healthcare Conference Date: Monday, April 7, 2025Format: ...