Showcasing Global Utility of its QAPs at Point-of-Care Testing Conference MISSISSAUGA, Ontario, June 17, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix), a life sciences innovator, manufacturer, and exporter, announces that it is attending and presenting at the 2nd Asia Pacific Conference on Point of Care Testing for Infectious Diseases, taking place in Bangkok, Thailand from 19 to 21 June, 2025 ("POC 2025"). At POC 2025, Microbix will be presenting a poster of results a ...

CARMEL, Ind., June 10, 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 presentations at the American Diabetes Association's (ADA) 85th Scientific Sessions, taking place June 20-23. 2025, Chicago, IL. The findings presented in the posters demonstrate the mechanism of action of MBX 1416 and illustrate its ...

Summary of MBX Biosciences FY Conference Call Company Overview - **Company**: MBX Biosciences - **Industry**: Clinical stage biopharmaceuticals focused on peptide therapeutics - **Key Focus**: Development of innovative peptide-based therapies for chronic hyperparathyroidism (HP), post-bariatric hypoglycemia (PBH), and obesity [2][3] Core Points and Arguments - **Significant Year Ahead**: 2025 is projected to be a pivotal year with the upcoming release of AVAIL Phase II data for the first PTH replacement therapy prodrug, Canbuparatide [2] - **PEP Technology**: MBX utilizes a proprietary PEP technology to create therapies with continuous infusion-like pharmacokinetics (PK) and infrequent dosing regimens [3][4] - **Pipeline**: - **Canbuparatide**: A potential once-weekly PTH replacement therapy with orphan drug designation in the US, currently in Phase II trials [5][11] - **MBX1416**: A potential once-weekly therapy for PBH, with plans for Phase II trials following positive Phase I results [5][21] - **Obesity Portfolio**: Includes MBX4291, a GLP-1 GIP coagonist prodrug aimed at once-monthly dosing [6][29] Financial Position - **Funding**: MBX ended the last quarter with over $240 million, expected to support operations into mid-2027 [4] Clinical Development Highlights - **Canbuparatide**: - Phase I results showed favorable safety and tolerability, with a flat infusion-like PK profile [13][14] - Phase II trial fully enrolled with 64 patients, aiming for a statistically significant treatment effect [15][17] - **MBX1416**: - Designed to be the first approved once-weekly treatment for PBH, with a favorable safety profile demonstrated in Phase I studies [21][22] - **MBX4291**: - Expected to file an IND this quarter, with a Phase I study planned to demonstrate once-monthly dosing and improved tolerability [29] Market Opportunities - **Chronic Hyperparathyroidism**: Affects over 250,000 people in the US and EU, with current treatments inadequate [10] - **Post-Bariatric Hypoglycemia**: Estimated prevalence over 90,000 in the US, with no approved pharmacotherapy available [18][20] - **Obesity**: Recognized as a global epidemic, with MBX aiming to address the heterogeneous needs of this population through innovative therapies [23][24] Unique Selling Proposition - **Differentiated PK Profile**: MBX's therapies aim to reduce side effects associated with rapid concentration peaks seen in current treatments, potentially leading to better patient adherence and outcomes [25][27] Conclusion - MBX Biosciences is positioned to make significant advancements in the treatment of chronic HP, PBH, and obesity through its innovative peptide technologies and well-funded pipeline, with multiple near-term milestones expected to create value [30]

MBX Biosciences (MBX) 2025 Conference June 04, 2025 02:00 PM ET Speaker0 Right. Good afternoon, everyone. Thank you Speaker1 for joining us on our next session. I'm Michael Yee, a biotechnology analyst at Jefferies. I am really pleased to have members of the team from MBX here with us, CEO Kent Harlock, as well as CMO Sam Azole. And importantly, the company is going Speaker0 to give a brief overview Speaker1 of what's going on at MBX. And obviously, I'm very excited about the upcoming data in the third quar ...

Group 1 - The article discusses the importance of staying updated on stocks in the biotech, pharma, and healthcare industries, particularly focusing on glucagon-like peptide receptor agonists (GLP-RA or GLP-1s) [1] - It highlights the services provided by the Haggerston BioHealth investing group, which includes catalysts for investment decisions, sales forecasts, and financial analyses for major pharmaceutical companies [1] - The author, Edmund Ingham, has extensive experience in biotech consulting and has produced detailed reports on over 1,000 companies in the sector [1]

Summary of MBX Biosciences Conference Call Company Overview - **Company**: MBX Biosciences - **Industry**: Clinical stage biopharmaceuticals focusing on peptide technology - **Key Technology**: Precision Endocrine Peptide (PEP) technology platform aimed at optimizing peptide therapies for endocrine diseases [3][4] Core Points and Arguments - **Financial Position**: MBX has $2.24 billion in funding as of the last quarter, expected to support operations until mid-2027 [4][5] - **Lead Indication**: Focus on chronic hypoparathyroidism (HP), affecting over 250,000 people in the US and EU [7] - **Current Treatment Landscape**: Standard care involves high doses of vitamin D and calcium supplements, which do not address the underlying PTH deficiency [8][9] - **New Therapy**: Camboparatide (CANVU) is a once-weekly PTH replacement therapy designed to improve patient convenience and outcomes compared to existing treatments [10][21] - **Phase One Data**: Positive results showing dose-dependent increases in serum calcium and a long half-life of 8-9 days, supporting once-weekly dosing [14][16] - **Phase Two Trial Design**: A 12-week trial with a fixed dose period followed by dose adjustments, aiming for a statistically significant treatment response rate of at least 55% [19][21] Competitive Landscape - **Market Entry**: The launch of Yorvy Path, a once-daily PTH replacement therapy, is seen as a positive development, with initial sales of approximately $50 million [26] - **Patient Demand**: There is significant demand for PTH replacement therapy among HP patients, who often feel inadequately managed on current supplements [27][28] Other Pipeline Programs - **Post-Bariatric Hypoglycemia (PBH)**: MBX is developing a long-acting GLP-1 antagonist for PBH, a condition with no approved pharmacotherapy, targeting a market comparable in size to HP [30][31] - **Obesity Program**: A new obesity treatment (4291) is in development, aiming for once-monthly dosing and improved tolerability compared to existing therapies like tirzepatide [38][40] Additional Insights - **Patient-Centric Approach**: The company emphasizes patient needs and aims to provide more effective treatment options [26][27] - **Regulatory Progress**: Plans to file an IND for the obesity program within the current quarter [43] - **Future Milestones**: The upcoming phase two results for CANVU are viewed as a transformative milestone for both the company and the field of HP treatment [24][44]

CARMEL, Ind., May 20, 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 following investor conferences: Goldman Sachs Global Healthcare Conference Date: June 9, 2025 Podium Presentation: June 9, 2025, 10:40 a ...

Core Insights - Microbix Biosystems Inc. reported Q2 and H1 fiscal 2025 results, showing a mixed performance with improved gross margins but a decline in overall revenues compared to the previous year [1][2][6]. Financial Performance - Q2 revenue was $5.3 million, a 5% decrease from $5.6 million in Q2 2024, with antigen revenues increasing by 5% to $4.3 million, while QAPs revenues fell by 38% to $864,320 due to delays in assay-development programs [3][10]. - H1 revenue totaled $11.4 million, a 19% decrease from $14.0 million in H1 2024, influenced by the absence of $4.1 million in Kinlytic licensing payments; excluding this, revenues increased by 14% [6][8]. - Gross margin for Q2 improved to 60% from 53% in the previous year, driven by better manufacturing efficiencies and pricing strategies [4][10]. - H1 gross margin was 61%, slightly down from 65% in H1 2024, but improved by 10% when excluding the impact of Kinlytic licensing revenues [7]. Operating Expenses and Income - Operating expenses in Q2 increased by 21% compared to Q2 2024, primarily due to higher investments in R&D and sales and marketing [4][10]. - Q2 net income was $20,664, a significant drop from $377,730 in Q2 2024, while H1 net income was $877,627 compared to $2.8 million in H1 2024, largely due to the absence of Kinlytic licensing fees [5][8]. Cash Position and Liquidity - Cash and equivalents at the end of Q2 stood at $14.5 million, an increase of $1.5 million from the previous quarter, despite debt repayments and share repurchases [5][10]. - The current ratio improved to 9.68, and the debt to equity ratio decreased to 0.27, indicating enhanced financial strength [9][10]. Business Outlook - Management expressed a cautious outlook for the second half of fiscal 2025, particularly for the Antigens business, due to reduced sales into China [2][11].

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 March 31, 2025 OR (I.R.S. Employer Identification No.) 11711 N. Meridian Street, Suite 300 Carmel, Indiana 46032 (Address of principal executive offices) (Zip Code) (317) 659-0200 Registrant's telephone number, including area code ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...

Exhibit 99.1 MBX Biosciences Reports First Quarter 2025 Financial Results and Recent Corporate Highlights Topline results for the Phase 2 Avail™ evaluating canvuparatide in patients with hypoparathyroidism expected in 3Q 2025 Post-bariatric Hypoglycemia (PBH): MBX 1416 • Phase 2 trial expected to be initiated in 2H 2025: In January, MBX reported Phase 1 top line results for its MBX 1416 long-acting GLP-1 receptor antagonist developed for the treatment of PBH. A Phase 2 trial is expected to be initiated in t ...