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 ...

MBX Biosciences (MBX) FY Conference June 09, 2025 10:40 AM ET Speaker0 Good morning. My name is Kent Harlech, and I'm the cofounder and CEO of MBX Biosciences. Speaker1 I would like to thank the Goldman Sachs team for the invitation to participate in this conference and to provide an opportunity to present an update on the company and what is promising to be our most important year in our company's history. With the data released next quarter of our AVAIL Phase II data for the first PTH replacement therapy ...

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 ...

If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth?In recent posts on Seeking Alpha, I have covered a number of companies developing drugs within a class most commonly referred to as glucagon-like peptide ("GLP") receptor agonists, or GLP-RA, or GLP-1s. These includ ...

纪要涉及的行业和公司 - 行业：生物制药行业 - 公司：MBX Biosciences (MBX) 纪要提到的核心观点和论据 公司概况 - MBX是临床阶段生物制药公司，与Richard DeMarkey有20年合作，此前合作公司与默克、罗氏和诺和诺德有交易 [3] - 公司采用PEP技术平台，已产生两个临床阶段项目，预计今年肥胖项目进入临床，截至上季度末资金达22.4亿美元，可支持运营到2027年年中 [3][4][5] 核心产品Canvoparatide（针对甲状旁腺功能减退症） - **疾病现状**：美国和欧盟超25万人受影响，目前标准治疗是补充剂，无法解决病因，有长期并发症，近期美国有每日一次PTH替代疗法Yorvy Path获批且上市情况良好 [7][8][9][10] - **产品优势**：每周一次PTH替代疗法前药，除方便外还有其他差异化优势，临床前数据显示在猴子中有持续输注样药物暴露，活性药物在PTH1受体上与PTH1 - 34或PTH有相当效力，在两种物种的IND启用毒性研究中显示安全，在PTX大鼠模型中可逆转疾病 [10][11][13] - **一期临床数据**：MAD数据符合预期，血清钙呈剂量依赖性增加，内源性PTH相应减少，PK符合设计，半衰期8 - 9天，稳态峰谷比与Yorvy Path一天内情况相当 [14][15][16] - **二期临床设计**：起始剂量400 - 800微克，有4周固定剂量期和8周剂量调整期，有两年开放标签扩展期，设计旨在显示临床概念验证，证明解决未满足需求的潜力，预计显示至少55%或安慰剂调整后48%的合并治疗反应率 [18][19][20][21] - **患者招募**：纳入标准与其他研究相似，主要是术后慢性甲状旁腺功能减退症患者，也包括先天性和自身免疫性患者，3月报告研究超额招募，目标48人，随机分配64人，预计第三季度提供顶线结果 [22][23] - **竞争格局**：Yorvy Path上市情况良好，预计PTH替代疗法会被更广泛采用，每周一次疗法更方便，维持期可能提供更多稳态和稳定性 [26][27][28] 产品1416（针对减肥后低血糖症） - **疾病现状**：美国患病率与甲状旁腺功能减退症相当，无获批药物治疗，标准治疗是严格饮食，难以维持，一些非标签药物耐受性差且临床数据少 [30] - **产品优势**：长效GLP - 1拮抗剂，半衰期90小时，可覆盖全周，防止GLP - 1增加引发的严重低血糖，一期数据积极，计划下半年进入二期 [32][33] - **一期临床数据**：耐受性良好，安全性良好，注射部位反应（ISRs）发生率高，88%为轻度至中度，严重ISRs与其他症状无关，会自发消失，有PD信号，内源性GLP - 1积累 [34][36][37] 产品4291（肥胖项目） - **市场现状**：肥胖市场大，但现有药物如tirzepatide有胃肠道副作用，停药率高，仅约10%能达到最高剂量，限制有效性 [39][40] - **产品优势**：每月一次给药是重要差异化点，可能有更好耐受性，Cmax上升慢，有望提高体重降低效果，计划进行一期研究，本季度提交IND申请 [41][42][43] 其他重要但可能被忽略的内容 - 公司开展的甲状旁腺功能减退症研究设置国外站点是为三期研究做准备，三期将更多在国外开展 [24] - 公司认为报销进展顺利，市场上PTH替代疗法成功对患者和MBX都有益 [29]

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 ...

Revenues of $5.3 million, Improved Gross Margin, and Positive Net IncomeMISSISSAUGA, Ontario, May 15, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, reports results for its second quarter and first half of fiscal 2025 ended March 31, 2025 (“Q2” and “H1”). Sales for Q2 and H1 reflected differential growth between Antigens (up) and QAPs™ (down), alongside a markedly-improved gross margin. Management DiscussionResult ...

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 ...

文章核心观点 MBX Biosciences公布2025年第一季度财务结果并强调近期公司进展，各项目取得良好进展且资金预计可支持运营至2027年年中 [1][2] 分组1：公司项目进展 - 2025年第一季度完成64名参与者招募超原目标，2025年第三季度有望公布用于治疗甲状旁腺功能减退症的canvuparatide（MBX 2109）2期Avail试验顶线数据 [3] - 用于治疗肥胖的GLP - 1/GIP共激动剂前药MBX 4291预计2025年第二季度提交研究性新药（IND）申请 [4] - 用于治疗减肥后低血糖症（PBH）的MBX 1416在2025年1月公布1期顶线结果，预计2025年下半年启动2期试验 [5] 分组2：公司人事变动 - 4月公司宣布任命Steve Hoerter为独立董事，其经验将助力公司下一阶段发展 [6] 分组3：2025年第一季度财务结果 - 截至2025年3月31日，公司现金、现金等价物和有价证券为2.408亿美元，预计可支持运营至2027年年中 [7] - 2025年第一季度研发费用为2240万美元，较2024年同期的1100万美元增加1140万美元，主要因MBX 4291的IND启用研究和canvuparatide的2期Avail试验成本增加 [12] - 2025年第一季度一般及行政费用为410万美元，较2024年同期的230万美元增加180万美元，因公司扩大基础设施支持业务增长带来人员相关成本增加 [12] - 2025年第一季度净亏损为2390万美元，而2024年同期净亏损为1230万美元 [12] 分组4：公司及平台介绍 - 公司专注基于专有PEP™平台发现和开发新型精准肽疗法，用于治疗内分泌和代谢疾病，其管线包括处于2期开发的canvuparatide、1期开发的MBX 1416及肥胖药物组合 [8] - 公司专有的Precision Endocrine Peptide™（PEP™）平台旨在克服未修饰和修饰肽疗法的关键限制，改善临床结果并简化患者疾病管理 [9]