AvailTM trial exceeded enrollment target; topline results expected in Q3 2025CARMEL, Ind., March 03, 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 completion of enrollment in its Phase 2 Avail™ trial of MBX 2109 (canvuparatide), the Company’s parathyroid hormone (PTH) peptide prodrug. Canvuparatide ...

Core Insights - Microbix Biosystems Inc. hosted Ontario Premier Doug Ford and MPP Deepak Anand to discuss the impact of next-generation diagnostic tests on health outcomes and healthcare costs [1][2] - The company has received over C$ 2.0 million in grant funding from the Ontario Together Funds, which has supported the development of innovative healthcare products [2] - Microbix is recognized as a leading life sciences company in Ontario, focusing on the manufacturing and export of diagnostic products [2][3] Company Overview - Microbix Biosystems Inc. specializes in proprietary biological products for human health, employing over 120 skilled workers and targeting monthly sales of C$ 2.0 million or more [3] - The company produces critical ingredients for the global diagnostics industry, including antigens for immunoassays and laboratory quality assessment products (QAPs™) [3][4] - Microbix's QAPs are sold in over 30 countries and are used by clinical lab accreditation organizations and diagnostics companies [3] Product Development - The company is also involved in developing proprietary products such as Kinlytic urokinase, a thrombolytic drug for treating blood clots, and reagents for molecular diagnostic testing [4] - Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, and provides IVDR-compliant CE marked products [3]

Core Points - Microbix Biosystems Inc. has announced the issuance of stock options under its shareholder-approved Stock Option Plan to incentivize and retain its board of directors, executives, and managers [1][2] - A total of 2,895,000 options have been approved, exercisable at a price of $0.48 per share, vesting after three years and having a total life of five years [2][4] - The stock options are allocated across 37 senior personnel, with an estimated quarterly expense of $61,000, representing approximately 2% of total company compensation costs [4] Stock Option Plan Details - The Stock Option Plan allows for the issuance of options representing up to 10% of Microbix's issued and outstanding common shares [5] - Prior to the current issuance, 11,009,000 options were outstanding with an average exercise price of $0.48 and an average remaining life of 2.55 years [5] - Following the current issuance, a total of 13,904,000 options will be outstanding, utilizing approximately 98% of the current plan availability [5] Company Overview - Microbix Biosystems Inc. specializes in creating proprietary biological products for human health, targeting annualized sales of C$2.0 million or more per month [6] - The company produces critical ingredients for the global diagnostics industry, including antigens for immunoassays and laboratory quality assessment products (QAPs™) [6] - Microbix is ISO 9001 & 13485 accredited and registered with U.S. FDA, Australian TGA, and Health Canada, providing IVDR-compliant CE marked products [6][7]

Company Overview - Microbix Biosystems Inc. is a life sciences innovator, manufacturer, and exporter, focusing on proprietary biological products for human health [3] - The company has over 120 skilled employees and aims for sales of C$ 2.0 million or more per month [3] - Microbix produces critical ingredients and devices for the global diagnostics industry, including antigens for immunoassays and laboratory quality assessment products (QAPs™) [3][4] Product Offerings - Microbix's antigens are utilized in antibody tests by approximately 100 diagnostics manufacturers [3] - QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs, and are available in over 30 countries [3] - The company also develops proprietary products such as Kinlytic® urokinase, a biologic thrombolytic drug, and reagents for molecular diagnostic testing [4] Upcoming Events - Microbix will present to equity investors at the Whistler Capital Event conference from February 21 to 23, 2025 [1] - CEO Cameron Groome will conduct 18 one-on-one meetings with growth company equity investors during the conference [2] - Presentation slides will be available on the Microbix website alongside other business information and financial disclosures [2] Industry Context - Capital Event Management Ltd. organizes multiple investor events annually, facilitating relationships between public/private companies and investors [5] - The Whistler Capital Event aims to enhance awareness within the investment community and support financing opportunities [5]

Company Overview - MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for endocrine and metabolic disorders [3] - The company is advancing a pipeline that includes canvuparatide for chronic hypoparathyroidism in Phase 2 development, MBX 1416 for post-bariatric hypoglycemia in Phase 1 development, and an obesity portfolio including MBX 4291 with an IND filing anticipated in Q2 2025 [3] Upcoming Events - Kent Hawryluk, President and CEO of MBX Biosciences, will present at the TD Cowen 45th Annual Healthcare Conference on March 3, 2025, from 10:30 a.m. to 11:00 a.m. ET in Boston, MA [1] - The company will also participate in the Jefferies Biotech on the Beach Summit on March 12, 2025, with a format of 1x1 meetings in Miami Beach, FL [2] - Presentation webcasts will be accessible on the investors section of the MBX Biosciences website, with replays available approximately two hours after the events [2]

Core Insights - Microbix Biosystems Inc. reported Q1 fiscal 2025 revenues of $6.0 million, reflecting a 40% year-over-year increase in recurring sales from diagnostic-test related ingredients and devices [1][2][3] Financial Performance - Total revenue for Q1 was $6,044,002, with antigen revenues at $4,266,758, marking a significant 118% increase from the previous year [3] - QAPs revenues were $1,626,980, down 28% from last year due to reduced activity from test manufacturers [3] - Net income for the quarter was $0.9 million, compared to $2.5 million in Q1 2024, which included non-recurring Kinlytic licensing revenues [6][8] - Gross margin percentage for Q1 was 62%, down from 74% in the prior year, but improved from 49% when excluding Kinlytic revenues [4] Operating Expenses - Operating expenses decreased by 23% compared to Q1 2024, primarily due to lower consulting fees related to the Kinlytic licensing agreement [5] Cash Flow and Ratios - Cash provided by operating activities was $792,702, down from $1,338,952 in Q1 2024 [6][9] - Current ratio at the end of Q1 was 6.62, and debt-to-equity ratio was 0.36, both affected by share repurchases [7][9] Corporate Outlook - The company aims to continue driving sales growth across all business lines and expects meaningful year-over-year revenue growth for the full fiscal year 2025 [10]

Company Overview - Microbix Biosystems Inc. is a life sciences innovator, manufacturer, and exporter, focusing on proprietary biological products for human health [4] - The company has over 120 skilled employees and aims for revenues of C$ 2.0 million or more per month [4] - Microbix specializes in critical ingredients and devices for the global diagnostics industry, including antigens for immunoassays and laboratory quality assessment products (QAPs™) [4] Upcoming Financial Results - Microbix is set to file its financial statements and management disclosure for Q1 2025, which ended on December 31, 2024, prior to trading on February 13, 2025 [1] - A webinar discussion regarding the Q1 2025 results will be held at 11:00 AM ET on the same day, featuring the CEO, CFO, and COO [1] Webinar Participation - Investors and shareholders can participate in the webinar by registering through a provided link, and it will also be live-streamed on YouTube [2] - A replay of the webinar will be available on Adelaide Capital's YouTube channel [3] Product and Market Focus - Microbix's antigens are utilized in antibody tests by approximately 100 diagnostics manufacturers, while QAPs are sold to clinical lab accreditation organizations and clinical labs [4] - The company's QAPs are available in over 30 countries, supported by a network of international distributors [4] - Microbix also develops proprietary products such as Kinlytic® urokinase, a biologic thrombolytic drug, and reagents for molecular diagnostic testing [5]

Core Viewpoint - Microbix Biosystems Inc. has raised C$ 2.4 million through the partial exercise of expiring share purchase warrants, which will be utilized to enhance product development, manufacturing capacity, and operational efficiency [1][3]. Group 1: Capital Raise and Warrant Details - The company received C$ 2.4 million from the exercise of 6,703,314 out of 8,881,564 remaining 2020 Warrants, representing 75.5% of the unexercised warrants [2][4]. - The 2020 Warrants were originally issued in January 2020 at an exercise price of C$ 0.36 with a five-year term [2]. Group 2: Use of Proceeds - The additional capital will be directed towards broadening product development capabilities, expanding manufacturing capacity, and improving operational efficiency [3]. - A portion of the funds may also be allocated to debt reduction or share repurchases under the company's Normal-Course Issuer Bid [3]. Group 3: Financial Position - Following the warrant exercises, Microbix has a current ratio of over 7.0 times and a debt-to-equity ratio of approximately 0.30, indicating strong financial health [5]. - The company's cash and equivalents balance exceeds C$ 15 million after the warrant exercises [4]. Group 4: Company Overview - Microbix Biosystems specializes in creating proprietary biological products for human health, targeting sales of C$ 2.0 million or more per month [6]. - The company manufactures critical ingredients for the global diagnostics industry, including antigens for immunoassays and laboratory quality assessment products (QAPs™) [6]. - Microbix is ISO 9001 & 13485 accredited and registered with U.S. FDA, Australian TGA, and Health Canada, ensuring compliance with international standards [6][7].

Company Overview - MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for endocrine and metabolic disorders [3] - The company is based in Carmel, Indiana and utilizes its proprietary PEP™ platform to advance its pipeline of candidates [3] Pipeline Development - The lead product candidate, MBX 2109, is in Phase 2 development for chronic hypoparathyroidism (HP) [3] - MBX 1416 is in Phase 1 development for post-bariatric hypoglycemia (PBH) [3] - The obesity portfolio includes MBX 4291 and multiple discovery and pre-clinical candidates aimed at treating obesity [3] Upcoming Investor Conferences - Kent Hawryluk, President and CEO, will present at the Guggenheim SMID Cap Biotechnology Conference on February 5, 2025, from 2:00 - 2:25 p.m. EST in New York, NY [1] - He will also participate in the BIO CEO & Investor Conference on February 10, 2025, from 11:00 a.m. – 12:00 p.m. EST in New York, NY [2] - Additionally, he will present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference virtually on February 11, 2025, from 8:40 - 9:10 a.m. EST [2]

Core Insights - Microbix Biosystems Inc. and American Proficiency Institute have launched a pilot proficiency testing program to validate molecular diagnostic assays for detecting the H5N1 strain of the Influenza A virus, which poses a potential pandemic threat [1][2] Group 1: Company Overview - Microbix Biosystems Inc. is a life sciences innovator focused on creating proprietary biological products for human health, with over 100 employees and monthly sales targeting C$ 2.0 million or more [4] - The company manufactures and exports critical ingredients and devices for the global diagnostics industry, including antigens for immunoassays and laboratory quality assessment products (QAPs™) [5] - Microbix's QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs, and are available in over 30 countries [5] Group 2: Industry Context - The H5N1 strain of the Influenza A virus is a novel strain that has shown the ability to infect birds, cattle, and humans, raising concerns about its potential to cause a pandemic [1] - The proficiency testing program aims to ensure that clinical laboratories can reliably detect H5N1 Flu using established molecular diagnostic tests, which include both regulator-approved assays and laboratory-developed tests [1] - API's proficiency testing programs are internationally accredited and support over 20,000 clinical laboratories, enhancing the accuracy and efficiency of clinical laboratory testing [3]