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: ...

Debt Repayment & Credit Expansion Provides Savings & Maintains ResilienceMISSISSAUGA, Ontario, March 26, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces the further optimization of the structure and utilization of its capital via the repayment of mortgage debt and expansion of its bank line of credit – moves that reduce interest expenses while maintaining strategic flexibility and resilience. Per its Q1 f ...

Product Candidates - Canvuparatide, the lead product candidate, is designed for once-weekly administration to treat chronic hypoparathyroidism, with Phase 2 topline data expected in Q3 2025[23]. - MBX 1416, a long-acting GLP-1 receptor antagonist, aims to address post-bariatric hypoglycemia, with a Phase 2 trial initiation planned for the second half of 2025[23]. - MBX 4291, a GLP-1/GIP co-agonist prodrug for obesity, has shown potential for once-monthly administration and is expected to submit an IND in Q2 2025[30]. - Canvuparatide demonstrated a low peak-to-trough ratio in Phase 1 trials, supporting its potential as a continuous infusion-like therapy[32]. - Canvuparatide, the lead product candidate, is designed for once-weekly administration and has demonstrated a low peak-to-trough ratio in Phase 1 trials, potentially enabling the first once-weekly PTH dosing regimen for patients with chronic hypoparathyroidism (HP)[45]. - The ongoing Avail™ Phase 2 clinical trial involves 64 patients and aims to evaluate the efficacy of canvuparatide over a 12-week period, with a primary endpoint of discontinuing active vitamin D and reducing calcium supplements[71]. - MBX 1416 is a long-acting GLP-1 receptor antagonist designed to prevent severe hypoglycemia in patients with PBH, with a potential for once-weekly administration[87]. - The obesity portfolio includes MBX 4291, a long-acting GLP-1/GIP receptor co-agonist prodrug, with IND submission anticipated in Q2 2025[108]. Market Opportunity - The company estimates that chronic hypoparathyroidism affects over 250,000 people in the U.S. and Europe, while post-bariatric hypoglycemia affects more than 90,000 people in the U.S.[32]. - The global sales of peptide-based therapies exceeded $50 billion in 2019, indicating a significant market opportunity for the company's products[35]. - The obesity market presents a significant commercial opportunity, with an estimated 190 million adults in the U.S. classified as obese or overweight[109]. - Current GLP-1-based therapies require weekly injections and can cause significant gastrointestinal side effects, highlighting the need for better-tolerated alternatives[113]. Technology and Development - The PEP platform is engineered to provide peptides with extended time-action profiles and low peak-to-trough ratios, enhancing efficacy and tolerability[25]. - The PEP platform includes advanced chemical modifications and programmable prodrug technologies aimed at improving stability, solubility, and clinical outcomes[28]. - The company has developed significant know-how in creating proprietary PEPs with novel mechanisms of action and enhanced pharmacokinetic profiles[42]. - Canvuparatide incorporates programmable prodrug technology and fatty acylation to achieve sustained PTH peptide levels and convenient dosing[51]. - The design of MBX 4291 incorporates prodrug and fatty acylation mechanisms to extend its time-action profile, potentially allowing for improved tolerability and weight loss outcomes[116]. Clinical Trials and Results - The FDA has granted Orphan Drug Designation to canvuparatide for the treatment of HP, with enrollment in the Phase 2 clinical trial completed in March 2025 and topline data expected in Q3 2025[45]. - In Phase 1 clinical trials, canvuparatide was well-tolerated with no severe drug-related adverse effects, and hypercalcemia was observed in 3 subjects at higher doses[59]. - The half-life of canvuparatide was approximately 7.7 to 8.9 days, supporting a once-weekly dosing regimen[60]. - Maximal increases in serum calcium levels were observed approximately 48 hours after canvuparatide injections, with nearly maximal effects after the third weekly injection[63]. - Phase 1 clinical trial results indicated that MBX 1416 was generally well-tolerated, with no dose-related serious adverse events and injection site reactions resolving within about seven days[96]. - The pharmacokinetic data showed that MBX 1416 achieved a median half-life of approximately 90 hours, supporting once-weekly dosing, with steady state reached by the third dose[97]. Competitive Landscape - Direct competitors for HP include Ascendis Pharma and AstraZeneca, while competitors for PBH include Xeris Pharmaceuticals and Amylyx Pharmaceuticals[134]. - Eli Lilly and Company has several obesity compounds in development, including tirzepatide, which is expanding indications and labeling, and Orforglipron, currently in Phase 3 trials[136]. - Novo Nordisk received FDA approval on March 8, 2024, for semaglutide to reduce the risk of heart attacks, strokes, and cardiovascular-related death in overweight or obese patients with heart disease[136]. - Amgen is developing MariTide/AMG-133, a potential once-monthly injectable currently in Phase 2 clinical development[136]. - Pfizer is developing danuglipron, a potential twice-daily oral GLP-1 receptor agonist currently in Phase 3 clinical development[136]. - Zealand Pharma is developing Survodutide, a long-acting once-weekly injectable GLP-1/glucagon receptor co-agonist currently in Phase 3 clinical development[136]. Regulatory Environment - The FDA may grant a patent term extension of up to five years for drugs approved in the U.S., but only one patent can be extended[144]. - The FDA requires annual progress reports for clinical trials and IND safety reports within 15 days for serious adverse reactions[159]. - The FDA aims to review NDAs for new molecular entities within 10 months, with priority reviews taking 6 months[170]. - The accelerated approval pathway allows for drugs to be approved based on surrogate endpoints that predict clinical benefit[172]. - Post-approval, drugs are subject to ongoing FDA regulation, including recordkeeping and reporting of adverse experiences[178]. - Companies must conduct additional post-approval studies to confirm clinical benefits for drugs granted accelerated approval[175]. - The FDA may require Risk Evaluation and Mitigation Strategies (REMS) to ensure the benefits of a product outweigh its risks[165]. Intellectual Property - The patent for canvuparatide is expected to expire in 2041, with pending applications in multiple countries[140]. - The patent for MBX 1416 is expected to expire no earlier than 2042, with 28 foreign patent applications pending[141]. - The patent applications for MBX 4291 are expected to expire in 2045, with claims directed to composition of matter and method of treatment[142]. - The company aims to protect its proprietary technology through patents, trademarks, and trade secrets[135]. Financial Considerations - Coverage and reimbursement for drug products in the U.S. can differ significantly among third-party payors, impacting sales and financial condition[210]. - The company may need to conduct expensive pharmacoeconomic studies to demonstrate the medical necessity and cost-effectiveness of its products[211]. - Governments are increasingly implementing cost-containment programs, which may include price controls and restrictions on reimbursement for drugs[212]. - The ACA enacted in 2010 significantly changed the financing of healthcare, affecting the pharmaceutical industry through various provisions[218].

Financial Position - As of December 31, 2024, MBX Biosciences reported unaudited cash, cash equivalents, and marketable securities totaling $262.1 million[6]. - The company anticipates that the ongoing audit of its consolidated financial statements for the year ended December 31, 2024, may result in changes to the reported financial information[6]. - The company is subject to various risks and uncertainties that could impact its business and financial condition, including those related to clinical trials and regulatory approvals[13]. Clinical Trial Results - The Phase 1 trial of MBX 1416 for the treatment of post-bariatric hypoglycemia (PBH) showed positive topline results, supporting progression to Phase 2 expected in the second half of 2025[10]. - The Phase 1 trial results are not necessarily indicative of future outcomes, and early-stage trials may not predict later-stage results[13]. - The company issued a press release on January 7, 2025, announcing the positive Phase 1 topline results for MBX 1416[9]. Drug Tolerability and Pharmacodynamics - MBX 1416 was generally well-tolerated with no dose-related serious adverse events observed, and 88% of injection site reactions were mild or moderate[12]. - In the multiple ascending dose cohort, MBX 1416 had a median half-life of approximately 90 hours, indicating potential for once-weekly administration[12]. - The drug demonstrated an increase in GLP-1 levels within 60 minutes of a mixed meal tolerance test, suggesting a pharmacodynamic effect that may benefit PBH patients[12]. - MBX 1416 showed no meaningful effect on the exposure of rosuvastatin, a commonly prescribed statin, during the drug-drug interaction portion of the trial[12].

Core Insights - MBX Biosciences is making significant progress in its clinical trials, particularly with canvuparatide for hypoparathyroidism, with topline results expected in Q3 2025 [2][7] - The company is preparing to initiate a Phase 2 trial for MBX 1416 in post-bariatric hypoglycemia in the second half of 2025 [2][3] - An Investigational New Drug (IND) submission for MBX 4291, aimed at obesity treatment, is anticipated in Q2 2025 [4] Clinical Development - Enrollment for the Phase 2 Avail trial of canvuparatide has been completed with 64 patients, and results are expected in Q3 2025 [7] - Positive results from the Phase 1 trial of MBX 1416 support its advancement to Phase 2, with the trial expected to start in the latter half of 2025 [3] - The IND filing for MBX 4291 is on track for Q2 2025, targeting a once-monthly treatment for obesity [4] Financial Performance - As of December 31, 2024, MBX Biosciences reported $262.1 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into mid-2027 [12][18] - Research and development expenses for Q4 2024 were $15.2 million, up from $7.7 million in Q4 2023, reflecting increased costs associated with ongoing clinical trials [12][16] - The net loss for the full year 2024 was $61.9 million, compared to a net loss of $32.6 million in 2023 [12][16] Corporate Developments - The company has strengthened its leadership team with new appointments in March 2025, enhancing expertise in pharmaceutical development and regulatory affairs [5] - MBX Biosciences is focused on developing precision peptide therapies for endocrine and metabolic disorders, leveraging its proprietary PEP™ platform [8][9]

Core Points - Microbix Biosystems Inc. has signed a Memorandum of Understanding (MOU) with the Australian Centre for the Prevention of Cervical Cancer (ACPCC) to supply PROCEEDx™FLOQ Quality Assessment Products (QAPs) for HPV testing [1][2] - The partnership aims to enhance the quality management of testing for high-risk HPV infections, which are responsible for most cervical cancer cases [1][4] - The EPICC program, supported by the Australian Government, aims to eliminate cervical cancer in the Indo-Pacific region through improved prevention, diagnosis, and treatment [2][8] Company Overview - Microbix Biosystems Inc. is a life sciences innovator with over 120 employees, targeting sales of C$ 2.0 million or more per month [5] - The company specializes in manufacturing and exporting critical ingredients and devices for the global diagnostics industry, including antigens for immunoassays and laboratory QAPs [5][6] - Microbix's products are available in over 30 countries and are supported by a network of international distributors, with various accreditations including ISO 9001 & 13485 [5][6] Industry Context - The EPICC program is a humanitarian initiative that has already shown success in countries like Malaysia and Papua New Guinea, and is now expanding to include 12 Indo-Pacific nations [3] - The ACPCC has been operating for 60 years, focusing on preventing cervical cancer through vaccination and screening programs [7] - The EPICC consortium includes leading Australian cancer research partners and aims to advance national cervical cancer elimination strategies in collaboration with Ministries of Health in the region [8]

Core Insights - MBX Biosciences has appointed Chatan Charan, Ph.D. as Senior Vice President of Pharmaceutical Development and CMC, and Mark Hope as Senior Vice President of Regulatory and Quality, indicating a strategic move to enhance its leadership team for future growth [1][2][3] Company Overview - MBX Biosciences is a clinical-stage biopharmaceutical company focused on developing novel precision peptide therapies for endocrine and metabolic disorders, utilizing its proprietary PEP™ platform [4] - The company is advancing a pipeline that includes canvuparatide (MBX 2109) for chronic hypoparathyroidism in Phase 2, MBX 1416 for post-bariatric hypoglycemia in Phase 1, and an obesity portfolio with multiple candidates in various stages of development [4] Leadership Experience - Chatan Charan, Ph.D. brings over 30 years of drug development experience, previously serving at Harpoon Therapeutics and Nektar Therapeutics, where he held significant roles in product development and strategy [2][3] - Mark Hope has over 30 years of regulatory experience, having held leadership positions at Cerevel Therapeutics and Leal Therapeutics, focusing on regulatory affairs and access strategies [3]