Welcome to our dedicated page for MBX Biosciences SEC filings (Ticker: MBX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The MBX Biosciences, Inc. (Nasdaq: MBX) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. As a clinical-stage biopharmaceutical company and emerging growth company, MBX uses filings such as Forms S-1, 10-K, 10-Q, and 8-K to describe its Precision Endocrine Peptide™ (PEP™) platform, clinical programs, risk factors, and capital-raising activities.
In its S-1 registration statement, MBX outlines its focus on novel precision peptide therapies for endocrine and metabolic disorders and details key product candidates, including canvuparatide (MBX 2109) for chronic hypoparathyroidism, imapextide (MBX 1416) for post-bariatric hypoglycemia, and MBX 4291 for obesity. Subsequent 8-K filings report material events such as topline results from the Phase 2 Avail™ trial of canvuparatide, initiation of the Phase 1 trial of MBX 4291, public equity offerings, and changes in board and committee roles.
Through this page, users can review MBX’s periodic financial reports, which discuss research and development spending, cash and marketable securities, and expectations about funding operations, as well as prospectus materials that describe intended uses of offering proceeds. Form 8-K filings also summarize key clinical data, trial designs, and future development plans for the company’s programs.
Stock Titan enhances these filings with AI-powered summaries that highlight the main points of lengthy documents, helping readers quickly understand topics such as clinical results, financing terms, and governance updates. Real-time updates from EDGAR, along with structured access to material event reports and registration statements, make this page a central resource for analyzing MBX’s regulatory and financial disclosures.
MBX Biosciences, Inc. (MBX) reported that the first patient has been dosed in its pivotal Phase 3 oPTimize trial of once-weekly canvuparatide for adults with chronic hypoparathyroidism. This global, randomized, double-blind, placebo-controlled study is intended as a registrational trial and uses the same device planned for potential commercial use.
The trial will enroll approximately 160 adults with chronic hypoparathyroidism, randomized 3:1 to canvuparatide or placebo over a 26‑week double-blind period, followed by a 78‑week open-label extension. Dosing includes a fixed 600 microgram period, titration up to 1,600 micrograms weekly, and a maintenance phase. The primary endpoint is a composite responder rate at Week 26 based on serum calcium control, reduced reliance on active vitamin D and calcium supplements, and dose stability. MBX highlights prior positive Phase 2 Avail data and notes that canvuparatide has Orphan Drug/Orphan Designation in the U.S. and EU.
MBX insider Peter K. Hawryluk filed to potentially sell 3,745 shares of common stock through Fidelity Brokerage Services. The shares relate to restricted stock vesting on August 14, 2026 and have an indicated aggregate market value of $255,737.06. MBX reports 48,160,096 common shares outstanding on NASDAQ. In the prior three months, Hawryluk sold 936 shares for $61,563.42.
MBX Biosciences, Inc. received an updated Schedule 13G/A (Amendment No. 2) from Deep Track Capital, LP, Deep Track Biotechnology Master Fund, Ltd., and David Kroin. The group reports beneficial ownership of 1,732,569 shares of common stock, representing 3.64% of the class as of June 30, 2026.
The reporting persons hold no sole voting or dispositive power, instead having shared voting and shared dispositive power over 1,732,569 shares. The percentage ownership is calculated using 47,597,536 shares outstanding as of May 4, 2026, as stated in MBX Biosciences’ Form 10-Q. The filing confirms ownership of 5% or less of the common stock.
MBX Biosciences, Inc. received an updated ownership report from several Frazier Life Sciences funds and related entities, filed as Amendment No. 3 to an existing beneficial ownership statement. The filing lists multiple Delaware venture funds and management entities, along with individual managers James N. Topper and Patrick J. Heron, as the reporting persons. Frazier Life Sciences Public Fund, L.P. directly holds 1,429,573 MBX common shares, representing 3.0% of the outstanding stock based on 48,160,096 shares outstanding as of August 3, 2026. Frazier Life Sciences X, L.P. directly holds 5,219,440 shares, or 10.8%, and Frazier Life Sciences XI, L.P. holds 3,000 shares, rounded to 0.0% of the class. Heron and Topper, through their roles in FHMLS X, L.L.C., share voting and investment power over the FLS X position; Topper is reported with 5,219,440 shares (an 11.7% stake), while Heron is reported with 5,243,421 shares (including 23,981 shares issuable upon option exercise), also reflecting an 11.7% interest. The amendment reflects a prior merger within Frazier funds, clarifies that working capital (not borrowed funds) financed these investments, and updates descriptions of the reporting entities’ organizational roles and ownership attributions.
OrbiMed Advisors and affiliates updated their ownership in MBX Biosciences, Inc. following recent share sales. OrbiMed-related funds now report beneficial ownership of 3,074,853 MBX common shares, representing 6.4% of the 48,160,096 shares outstanding as referenced in MBX’s Form 10-Q filed on August 6, 2026.
OrbiMed Private Investments VII, LP holds 2,505,150 shares (about 5.2%), and OrbiMed Genesis Master Fund, L.P. holds 569,703 shares (about 1.2%). The amendment states their beneficial ownership decreased by more than 1% as a result of open‑market sales between June 29 and August 7, 2026 at prices ranging from $53.48 to $68.29 per share. The filing also describes an Investors’ Rights Agreement granting OrbiMed funds demand, Form S-3, and piggyback registration rights for future potential resales of their MBX shares.
MBX Biosciences, Inc., a clinical-stage biopharmaceutical company focused on endocrine and metabolic disorders, reported a net loss of $37.1 million for the quarter ended June 30, 2026, compared with $19.4 million a year earlier. Operating expenses rose to $40.9 million, driven by higher research and development spending of $31.0 million as the company advanced canvuparatide (MBX 2109), MBX 4291, imapextide (MBX 1416) and preclinical programs; general and administrative expense increased to $9.9 million, mainly from headcount growth and stock-based compensation. Interest and other income of $3.8 million partly offset the operating loss.
For the first six months of 2026, net loss was $60.6 million. As of June 30, 2026, MBX held $418.6 million in cash, cash equivalents and marketable securities and had total assets of $435.9 million. This liquidity reflects proceeds from its IPO, a September 2025 underwritten offering and a February 2026 at-the-market sale of 2,250,986 shares, and the company believes these resources will fund its current operating plan into 2029.
Clinically, MBX completed End of Phase 2 interactions for canvuparatide and presented Phase 2 and one-year extension data, and plans to initiate a Phase 3 trial in the third quarter of 2026. A Phase 1 trial of obesity candidate MBX 4291 is ongoing, with 12‑week MAD cohort results expected in the fourth quarter of 2026; obesity candidates MBX 5765 and MBX 6180 are in IND‑enabling studies. Imapextide achieved proof of concept in post-bariatric hypoglycemia, but MBX does not plan further investment in a Phase 2b trial. After quarter end, founding CEO Kent P. Hawryluk departed, executive chair Steven Hoerter became President and CEO, and John Smither was appointed CFO. MBX expects to recognize $15–$20 million of stock-based compensation in the third quarter of 2026 related to the former CEO’s separation.
MBX Biosciences, Inc. reported second-quarter 2026 results and extensive pipeline progress in endocrine and metabolic disorders. As of June 30, 2026, it held $418.6 million in cash, cash equivalents and marketable securities, which management expects will fund operations into 2029. For the quarter, research and development expenses were $31.0 million and general and administrative expenses were $9.9 million, leading to a net loss of $37.1 million, or $0.78 per share.
The company highlighted once-weekly canvuparatide for chronic hypoparathyroidism, with the pivotal Phase 3 oPTimize trial expected to initiate in the third quarter of 2026 following Phase 2 and one-year open-label extension data showing sustained benefit. In obesity, preliminary Phase 1 data for MBX 4291 showed a mean weight loss of 7% at eight weeks in the first multiple ascending dose cohort and pharmacokinetics that support once-monthly dosing, with 12-week MAD results planned for the fourth quarter of 2026. MBX also nominated two additional once-monthly obesity candidates, MBX 5765 (amycretin) and MBX 6180 (GLP-1/GIP/GCG triple agonist), and appointed Steve Hoerter as Chairman and Chief Executive Officer and John Smither as Chief Financial Officer.
MBX Biosciences, Inc. reported that Chief Medical Officer Salomon Azoulay sold 370 shares of common stock on August 4, 2026 at a weighted average price of $65.77 per share to cover tax obligations from vesting restricted stock units under a mandatory sell-to-cover agreement, leaving 14,399 shares held directly.
MBX affiliate Peter Kent Hawryluk filed to sell 936 shares of common stock through Fidelity Brokerage Services LLC. The shares arose from restricted stock vesting on 08/03/2026 as compensation. The filing also notes a prior sale of 607 shares on 05/06/2026.
MBX filed to permit the sale of 370 shares of common stock, with an aggregate market value of $24,335.97, through Fidelity Brokerage Services LLC on NASDAQ on August 4, 2026. These shares arose from restricted stock vesting on August 3, 2026 as compensation from the issuer. The filing also lists prior sales by Salomon Azoulay in the past three months, including 231 shares for $6,824.78 on May 6, 2026 and 70,003 shares for $2,685,680.90 on May 8, 2026.