Core Insights - Microbix Biosystems Inc. is expanding its platform capabilities to produce a wider range of recombinant antigens, enhancing its market share as a supplier to immunoassay manufacturers [1][3]. Group 1: Company Overview - Microbix has over three decades of experience as a leading producer of purified and inactivated antigens, supplying over 100 international manufacturers of immunoassays [2]. - The company reported sales of native antigens totaling C$ 13.8 million in fiscal 2024, marking a 44% increase from the previous year [2]. - Microbix is ISO 9001 & 13485 accredited and registered with U.S. FDA, Australian TGA, and Health Canada, ensuring compliance with international standards [6]. Group 2: Expansion Plans - The company plans to invest approximately C$ 0.5 million per year to enhance its internal capabilities in synthetic biology for the production of recombinant antigens [4]. - By the end of 2025, this initiative is expected to broaden the total addressable market by offering a wider range of infectious-disease antigens at various price points [5]. - The recombinant antigens will also serve as ingredients for Microbix's QAPs test-controls, providing immediate internal validation for external customers [5]. Group 3: Market Position and Strategy - Microbix aims to leverage its expertise in recombinant technologies to produce antigens that can offer price advantages over native antigens without compromising assay performance [3]. - The company’s strategic focus on recombinant antigens is anticipated to significantly grow sales in this important segment of its business [3].

Phase 1 results support proceeding to Phase 2 in patients with post-bariatric hypoglycemia (PBH), which is expected to begin in 2H 2025 Phase 1 trial in healthy volunteers showed MBX 1416 was generally well-tolerated with a favorable safety profile Pharmacokinetic results demonstrated sustained dose-dependent exposure and support once-weekly dosing Company to host conference call to discuss results today at 8:30 am ET CARMEL, Ind., Jan. 07, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a cli ...

Core Insights - Microbix Biosystems Inc. reported record revenues of $25.4 million and net income of $3.5 million for the fiscal year 2024, reflecting strong growth in its diagnostic-test related ingredients and devices businesses [1][2][3]. Financial Performance - Total revenue for 2024 was $25,394,148, a significant increase of 54% from $16,514,776 in fiscal 2023 [3]. - Q4 revenue reached $6,293,897, marking a 48% increase from $4,264,229 in Q4 2023 [8]. - Antigen sales grew by 44% to $13,813,568 in 2024, while QAPs sales increased by 38% to $7,015,820 [3]. - Gross margin percentage improved to 61% in 2024 from 45% in 2023, driven by licensing fees and better product margins [4]. Operating Income and Expenses - Operating income for 2024 was $3,905,011, compared to an operating loss of $2,736,432 in 2023 [6]. - Operating and finance expenses increased by 11% in 2024 due to agent fees related to the Kinlytic transaction and investments in IT and R&D [5]. Cash Flow and Financial Ratios - Cash provided by operating activities was $4,347,620 in 2024, compared to cash used of $1,094,561 in 2023 [6]. - At the end of 2024, the current ratio was 7.15 and the debt-to-equity ratio was 0.35, indicating strong liquidity and low leverage [7]. Corporate Outlook - Management expects continued sales growth across all business lines and aims to improve gross margins while delivering positive bottom-line results in fiscal 2025 [12].

Company Overview - MBX Biosciences is a clinical-stage biopharmaceutical company focused on developing precision peptide therapies for endocrine and metabolic disorders using its proprietary PEP™ platform [3] - The company is advancing a pipeline of novel candidates targeting endocrine and metabolic disorders with clinically validated targets, established regulatory endpoints, significant unmet medical needs, and large market opportunities [3] - Key pipeline includes MBX 2109 (Phase 2 for chronic hypoparathyroidism), MBX 1416 (Phase 1 for post-bariatric hypoglycemia), and MBX 4291 (obesity portfolio) [3] Upcoming Events - The company's President and CEO, Kent Hawryluk, will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025, at 2:15 PM Pacific Time [1] - MBX Biosciences will participate in 1-on-1 investor meetings during the conference [1] - A live webcast of the presentation will be available on the company's investor website, with a replay accessible approximately two hours post-event and archived for 30 days [2]

Core Viewpoint - MBX Biosciences has completed the last subject's visit in its Phase 1 trial of MBX 1416, a long-acting GLP-1 receptor antagonist aimed at treating post-bariatric hypoglycemia (PBH), marking a significant milestone in the program [1][2] Group 1: Clinical Trial Details - The Phase 1 trial is a randomized, double-blind, placebo-controlled study involving 69 healthy adult participants, focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics of MBX 1416 [2] - The primary endpoint of the trial is safety and tolerability, while secondary endpoints include pharmacokinetics and pharmacodynamics [2] - Full topline results from the trial are expected to be shared in early January 2025 [2] Group 2: Product Information - MBX 1416 is designed to prevent severe hypoglycemia in individuals with PBH, utilizing the proprietary PEP™ platform developed by the company [3] - The product aims to improve the quality of life for patients suffering from PBH, a condition with no approved therapies to date [3][4] Group 3: Market Context - Post-bariatric hypoglycemia is a serious complication following bariatric surgery, characterized by recurrent hypoglycemic episodes, which can significantly impact daily activities and quality of life [4] - As the prevalence of bariatric surgeries increases, the incidence of PBH is expected to rise, highlighting the urgent need for effective treatments [4] Group 4: Company Overview - MBX Biosciences focuses on developing novel precision peptide therapies for endocrine and metabolic disorders, with a pipeline that includes MBX 2109 for chronic hypoparathyroidism and an obesity portfolio [5] - The company leverages its proprietary PEP™ platform to enhance the efficacy and safety of peptide therapies, aiming to address significant unmet medical needs [6]

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 September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |-----------------------------------------------------------------------------|-----------------------| | | | | For the transition period from _________________ to | _______ ...

Exhibit 99.1 MBX Biosciences Reports Third Quarter 2024 Financial Results and Provides Business Update Total gross proceeds from upsized initial public offering and Series C financing were approximately $251.2 million Last subject last visit in Phase 1 trial of MBX 1416 anticipated by late November; topline results to be reported in early January 2025 Enrollment of Phase 2 Avail™ trial of MBX 2109 in hypoparathyroidism on track to complete in Q1 2025; topline results anticipated in Q3 2025 Strong cash posit ...