Q1 Revenues of $4.2 million and Controlled Net Loss MISSISSAUGA, ON / ACCESS Newswire / February 12, 2026 / Microbix Biosystems Inc. (TSX:MBX)(OTCQX:MBXBF, Microbix® ), a life sciences innovator, manufacturer, and exporter, reports results for its first quarter of fiscal 2026 ended December 31, 2025 ("Q1"). Results for Q1 demonstrated the Company's efforts to rebuild revenues back above its breakeven point following two client setbacks in mid-2025, with revenue growth of 13% compared to Q4 fiscal 2025. ...

CARMEL, Ind., Feb. 11, 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 present at and participate in the following upcoming investor conferences: 36th Oppenheimer Annual Healt ...

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].