MBX Biosciences Files 8-K

Ticker: MBX · Form: 8-K · Filed: Sep 4, 2025 · CIK: 1776111

Sentiment: neutral

Topics: corporate-filing, regulatory

TL;DR

MBX Biosciences dropped an 8-K on 9/4/25. Check it for updates.

AI Summary

MBX Biosciences, Inc. filed an 8-K on September 4, 2025, reporting on other events and financial statements. The company, incorporated in Delaware, is based in Carmel, Indiana, and operates in the pharmaceutical preparations sector.

Why It Matters

This filing provides an update on MBX Biosciences' corporate activities and financial reporting, which is crucial for investors to stay informed about the company's status.

Risk Assessment

Risk Level: low — This filing is a routine 8-K for corporate reporting and does not appear to contain significant new risks or material adverse events.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing for MBX Biosciences, Inc.?

This 8-K filing serves as a current report for MBX Biosciences, Inc., covering 'Regulation FD Disclosure', 'Other Events', and 'Financial Statements and Exhibits' as of September 4, 2025.

When was the earliest event reported in this filing?

The earliest event reported in this filing is dated September 04, 2025.

In which state is MBX Biosciences, Inc. incorporated?

MBX Biosciences, Inc. is incorporated in Delaware.

What is the business address of MBX Biosciences, Inc.?

The principal executive offices of MBX Biosciences, Inc. are located at 11711 N. Meridian Street, Suite 300, Carmel, Indiana 46032.

What is the SIC code for MBX Biosciences, Inc.?

The Standard Industrial Classification (SIC) code for MBX Biosciences, Inc. is 2834, which corresponds to Pharmaceutical Preparations.

Filing Stats: 1,269 words · 5 min read · ~4 pages · Grade level 14 · Accepted 2025-09-04 08:09:06

Key Financial Figures

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On September 4, 2025, MBX Biosciences, Inc. (the "Company") issued a press release (the "Press Release") titled "MBX Biosciences Doses First Participant in Phase 1 Trial of MBX 4291 for the Treatment of Obesity." A copy of the Press Release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information included under Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing .

01 Other Events

Item 8.01 Other Events. On September 4, 2025, the Company announced the first dose of the first participant in a phase 1 trial of for MBX 4291, a long-acting glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist prodrug for the treatment of obesity. Topline results of the Phase 1 clinical trial of MBX 4291 are anticipated in 2027, and a summary of the trial design is as follows: Phase 1 trial design The Phase 1 trial is a randomized, double-blind, placebo-controlled first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of MBX 4291 in adult participants with obesity. The Phase 1 trial will include: Part A Single Ascending Dose (SAD) : single ascending doses of MBX 4291 or matching placebo will be administered in 5 cohorts consisting of 8 participants each. Participants will be randomized on Study Day 1 to receive MBX 4291 or matching placebo in a 3:1 ratio. Participants in each cohort will be followed for 63 days after the single study intervention administration. Part B Multiple Ascending Dose (MAD) (4 weeks) : multiple ascending doses of MBX 4291 or matching placebo will be administered in 3 cohorts consisting of 8 participants each. Participants will be randomized on Study Day 1 to receive MBX 4291 or matching placebo in a 3:1 ratio. Participants in each cohort will receive a total of 4 study intervention administrations one week apart and will be followed for 71 days after the first study intervention administration. Following completion of Parts A and B, the Company plans to evaluate multiple ascending doses of MBX 4291, or matching placebo, administered over 12 weeks in up to two cohorts consisting of 30 participants each in a 2:1 randomization ratio. Participants are expected to receive up to a total of 12 study intervention administrations one week or one week and one month apart with increasing doses of MBX 4291 and

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release Issued by MBX Biosciences, Inc. on September 4, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. MBX BIOSCIENCES, INC. Date: September 4, 2025 By: /s/ P. Kent Hawryluk President and Chief Executive Officer (Principal Executive Officer)

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