Novel Quality Controls to Enable QC & Inter-Laboratory Standardization MISSISSAUGA, ON / ACCESS Newswire / February 4, 2026 / Microbix Biosystems Inc. (TSX:MBX)(OTCQX:MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it is presenting results of its novel Quality Assessment Products ("QAPsâ"¢") and platform technology for supporting the quality management and reproducibility of Molecular Pathology derived diagnoses of infectious diseases at Labquality Days, a lab diagno ...

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]

Market Overview - U.S. stocks showed mixed performance, with the Dow Jones index declining approximately 0.2% on Wednesday [1] Company Highlights - Monte Rosa Therapeutics Inc (NASDAQ:GLUE) experienced a significant increase in share price, rising 45.2% to $23.25 after announcing interim data from a Phase 1 clinical study for MRT-8102 [1] - Ventyx Biosciences Inc (NASDAQ:VTYX) shares surged 37.5% to $13.82 following reports of advanced acquisition talks with Eli Lilly & Co. (NYSE:LLY) for over $1 billion [2] - Neumora Therapeutics Inc (NASDAQ:NMRA) saw a rise of 24.7% to $2.27 [2] - Regencell Bioscience Holdings Ltd (NASDAQ:RGC) increased by 21.1% to $40.00 [2] - Erasca Inc (NASDAQ:ERAS) rose 17.1% to $4.25, with Piper Sandler initiating coverage with an Overweight rating and a price target of $5 [2] - Anywhere Real Estate Inc (NYSE:HOUS) gained 15.6% to $16.71 [2] - AXT Inc (NASDAQ:AXTI) increased by 13.8% to $22.96 [2] - Immuneering Corp (NASDAQ:IMRX) rose 13.1% to $7.60 [2] - Compass Therapeutics Inc. (NASDAQ:CMPX) gained 13.1% to $5.56 [2] - MBX Biosciences Inc (NASDAQ:MBX) rose 11.2% to $31.90 [2] - Rezolve AI PLC (NASDAQ:RZLV) increased by 10.8% to $3.36 [2] - United Microelectronics Corp (NYSE:UMC) gained 10.4% to $8.96 after reporting sales growth for December and the full year [2] - PBF Energy Inc (NYSE:PBF) rose 9.2% to $29.73 [2] - Navan Inc (NASDAQ:NAVN) increased by 8.3% to $18.42 [2] - Ascentage Pharma Group International (NASDAQ:AAPG) gained 8.3% to $28.17 after announcing IND clearance for BTK Degrader APG-3288 by the U.S. FDA [2] - Intel Corp (NASDAQ:INTC) rose 6.4% to $42.60 as the company is enhancing its gaming strategy by developing a new chip for handheld gaming devices [2]

Core Viewpoint - Microbix Biosystems Inc. reported a significant decline in revenues for the fiscal year 2025, primarily due to reduced antigen sales into China and the cancellation of a client program, resulting in a net loss of $2.2 million [1][3][6]. Financial Performance - Total revenues for 2025 were $18.6 million, a 27% decrease from $25.4 million in 2024 [3]. - Antigen revenues decreased by 10% to $12.4 million, attributed to fewer respiratory infections in China [3]. - QAPs revenues fell by 20% to $5.6 million due to the cancellation of test-development programs by a large client [3]. - Revenue from royalties increased by 15% to $598,775 [3]. - Gross margin percentage for 2025 was 53%, down from 61% in 2024, mainly due to fixed manufacturing costs being spread over fewer units [4]. - Operating expenses increased by 4% in 2025, influenced by lower investment income and increased spending on trade shows and R&D [5]. Quarterly Performance - Q4 revenue was $3.7 million, a 41% decrease from $6.3 million in Q4 2024 [8]. - Antigen sales in Q4 dropped by 55% to $1.95 million, primarily due to weaker sales to the China distributor [8]. - QAPs revenues in Q4 decreased by 5% to $1.6 million [8]. - Q4 gross margin percentage was 40%, down from 55% in the previous year [9]. - The company reported a net loss of $1.5 million in Q4 compared to a net income of $440,324 in Q4 2024 [10]. Cash Flow and Financial Ratios - Cash used in operating activities for 2025 was $80,287, a significant decline from cash provided of $4.3 million in 2024 [6]. - Cash and equivalents at the end of September 2025 were $12.1 million [6]. - The current ratio was 8.48, indicating strong liquidity, while the debt to equity ratio remained stable at 0.35 [7]. Corporate Outlook - The company is focused on pursuing new client programs and expanding its product portfolio to drive sales growth and improve gross margins [13]. - Microbix aims to create sustained shareholder value through its diagnostics business and the Kinlytic® drug program [13].

Company Overview - MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing novel precision peptide therapies for endocrine and metabolic disorders [3] - The company is based in Carmel, Indiana and utilizes its proprietary PEP™ platform for drug discovery [3] Pipeline Development - MBX Biosciences 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, currently in Phase 1 development, along with multiple discovery and pre-clinical candidates [3] - Imapextide (MBX 1416) is in Phase 2 development for post-bariatric hypoglycemia [3] Upcoming Events - Kent Hawryluk, President and CEO, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco from January 12-15, 2026 [1] - The company presentation is scheduled for January 13, 2026, at 3:45 p.m. PT/6:45 p.m. ET [2] - A live webcast of the presentation will be available on the MBX Biosciences website, with a replay accessible for approximately 90 days [2]

Core Insights - Microbix Biosystems Inc. is set to release its Q4 2025 financial results on December 18, 2025, prior to market opening, followed by a webinar discussion with key executives [1] Company Overview - Microbix Biosystems Inc. specializes in proprietary biological products for human health, employing over 120 skilled workers and reporting revenues of C$ 25.4 million in the last fiscal year (2024) [3] - The company supports the global diagnostics industry by providing critical ingredients and devices, including antigens for immunoassays and laboratory quality assessment products (QAPs™) [3] - Microbix's products are utilized by approximately 100 diagnostics manufacturers, and its QAPs are available in over 30 countries through a network of international distributors [3] - The company is accredited with ISO 9001 & 13485, registered with the U.S. FDA, Australian TGA, and licensed by Health Canada, ensuring compliance with IVDR and CE marking [3] Product Development - Microbix also develops proprietary products such as Kinlytic® urokinase, a thrombolytic drug for treating blood clots, and reagents for molecular diagnostic testing [4]