# EDGAR Filing Document

**Accession Number:** 0001776111
**File Stem:** 0000950170-25-104602
**Filing Date:** 2025-8
**Character Count:** 17747
**Document Hash:** 24feeaacc53350c41ef9781db93e1bec
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-25-104602.hdr.sgml**: 20250807

**ACCESSION NUMBER**: 0000950170-25-104602

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20250807

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250807

**DATE AS OF CHANGE**: 20250807

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** MBX Biosciences, Inc.
- **CENTRAL INDEX KEY:** 0001776111
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-42272
- **FILM NUMBER:** 251191755

**BUSINESS ADDRESS:**
- **STREET 1:** 11711 N. MERIDIAN STREET
- **STREET 2:** SUITE 300
- **CITY:** CARMEL
- **STATE:** IN
- **ZIP:** 46032
- **BUSINESS PHONE:** 3179893100

**MAIL ADDRESS:**
- **STREET 1:** 11711 N. MERIDIAN STREET
- **STREET 2:** SUITE 300
- **CITY:** CARMEL
- **STATE:** IN
- **ZIP:** 46032

?xml version='1.0' encoding='ASCII'? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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## **FORM** 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** August 07, 2025<br>

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MBX Biosciences, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-42272 | 84-1882872 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 11711 N. Meridian Street<br>Suite 300 |  |  |
| Carmel**,** Indiana |  | 46032 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** (317) 659-0200<br>

Not Applicable

**(Former Name or Former Address, if Changed Since Last Report)**

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

**Securities registered pursuant to Section 12(b) of the Act:**

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common Stock, $0.0001 par value per share | MBX | Nasdaq Global Select Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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## **Item 2.02 Results of Operations and Financial Condition.** 
On August 7, 2025, MBX Biosciences, Inc. (the "Company") announced its financial results for the quarter ended June 30, 2025. 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 2.02 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.

## **Item 9.01 Financial Statements and Exhibits.** 
(d) Exhibits.

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| | |
|:---|:---|
| <u>Exhibit No.</u> | <u>Description</u> |
| 99.1 | [<u>Press Release Issued by MBX Biosciences, Inc. on August 7, 2025</u>](mbx-ex99_1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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**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.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | MBX Biosciences, Inc. |
| Date: | August 7, 2025 | By:  | /s/ P. Kent Hawryluk |
|  |  |  | President and Chief Executive Officer (Principal Executive Officer) |

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## Exhibit 99.1

**Exhibit 99.1**

![img258572290_0.jpg](img258572290_0.jpg)

**MBX Biosciences Reports Second Quarter 2025 Financial Results and Recent Corporate Highlights**

*Topline results for the Phase 2 Avail™ trial of canvuparatide in hypoparathyroidism on track for Q3 2025*

*Imapextide (MBX 1416) Phase 2a trial initiation in patients with post-bariatric hypoglycemia anticipated in Q3 2025*

*MBX 4291 Phase 1 trial initiation in obesity anticipated in Q3 2025*

*$224.9 million in cash, cash equivalents and marketable securities as of June 30, 2025; expected to support operations into mid-2027*

CARMEL, Ind., August 7, 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 reported financial results for the second quarter ended June 30, 2025, and highlighted recent corporate progress.

"We are pleased to report continuous clinical development progress across our entire pipeline of Precision Endocrine Peptide (PEP) product candidates with a number of value-creating milestones anticipated in the second half of this year," said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. "We look forward to sharing topline results from our Phase 2 Avail™ trial of canvuparatide in hypoparathyroidism this quarter. In addition, we are on track to initiate a Phase 2a clinical trial for imapextide, a peptide therapy for the treatment of post-bariatric hypoglycemia, and a Phase 1 trial evaluating MBX 4291 in patients with obesity, both in this quarter."

**Second Quarter 2025 and Recent Corporate Highlights**

<u>Hypoparathyroidism (HP): Canvuparatide (MBX 2109)</u> 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Phase 2 topline data from Avail trial expected in Q3 2025.** Topline results from the Phase 2 Avail trial of canvuparatide, a potential long-acting, once-weekly parathyroid hormone (PTH) peptide prodrug candidate, are on track to be reported in the third quarter of 2025.

<u>Post-bariatric Hypoglycemia (PBH): Imapextide (MBX 1416)</u> 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Patient screening underway in Phase 2a trial:** The Company has completed an end-of-Phase 1 meeting and a Phase 2a clinical trial evaluating imapextide, a long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist for the treatment of PBH, is

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expected to begin in the third quarter of 2025.

<u>Obesity: MBX 4291</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Phase 1 trial to initiate Q3 2025:** MBX 4291, a GLP-1/glucose-dependent insulinotropic polypeptide (GIP) co-agonist prodrug is being developed as a once-monthly treatment for patients with obesity. In June, the Company submitted an investigational new drug (IND) application for MBX 4291 and received clearance to proceed in July. A Phase 1 trial initiation is anticipated in the third quarter of 2025.

<u>Corporate</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Leadership team additions**: In June, MBX appointed Andreas Moraitis, M.D., as Senior Vice President of Clinical Development overseeing clinical advancement of canvuparatide.

**Second Quarter 2025 Financial Results**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•*Cash and Cash Equivalents and Marketable Securities*: As of June 30, 2025, MBX Biosciences had cash, cash equivalents and marketable securities of $224.9 million. Based on its current operating plan, management expects the combined cash, cash equivalents and marketable securities balance to fund operations into mid-2027.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•*R&D Expenses*: Research and development expenses for the three months ended June 30, 2025, were $17.7 million compared to $14.4 million for the same period in 2024. The increase of $3.3 million was driven by costs associated with ongoing IND-enabling studies for MBX 4291 and the ongoing canvuparatide Phase 2 clinical trial.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•*G&A Expenses*: General and administrative expenses for the three months ended June 30, 2025, were $4.1 million compared to $2.3 million for the same period in 2024. The increase of $1.8 million was driven by increased personnel-related costs as the Company expanded its infrastructure to support its growth in operations as a public company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•*Net Loss*: Net loss for the three months ended June 30, 2025, was $19.4 million compared to a net loss of $15.9 million for the same period in 2024.

# **About MBX Biosciences** 
MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company's pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism (HP) in Phase 2 development; imapextide (MBX 1416) for the treatment of post-bariatric hypoglycemia (PBH) in Phase 2 development; and an obesity portfolio that includes MBX 4291, in Phase 1 development, as well as multiple discovery and pre-clinical obesity candidates. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at <u>www.mbxbio.com</u> and follow it on <u>LinkedIn</u>.

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# **About MBX's Proprietary Precision Endocrine Peptide (PEP™) Platform** 
MBX was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing.

# **Forward-Looking Statements** 
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: MBX Biosciences' expectations regarding the Phase 2 Avail™ trial of canvuparatide, including the timing of topline results; statements related to the potential for canvuparatide to be a once-weekly PTH replacement therapy; the expected timing for the Phase 2a trial for imapextide and statements related to an end-of-phase 1 meeting with the FDA; statements related to the ability of imapextide to be a treatment of PBH; the expected timing of the initiation of a Phase 1 trial for MBX 4291; and expectations regarding MBX Biosciences' uses of capital, expenses and financial results, including the anticipated cash runway timing.

Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect MBX Biosciences' business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company's research and development activities; MBX Biosciences' ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to preclinical and clinical development activities; the Company's dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; MBX Biosciences' ability to attract, integrate and retain key personnel; risks related to the Company's financial condition and need for substantial additional funds in order to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining MBX Biosciences' intellectual property protections; and risks related to the competitive landscape for MBX Biosciences' product candidates; as well as other risks described in "Risk Factors," in MBX Biosciences' Quarterly Report on Form 10-Q for the three months ended June 30, 2025, Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC), as well as subsequent filings with the SEC. MBX Biosciences expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

MBX uses and intends to continue to use its Investor Relations website as a means of

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disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company's Investor Relations website, in addition to following the Company's press releases, SEC filings, public conference calls, presentations, and webcasts.

**Media Contact:**

Katie Beach Oltsik

Inizio Evoke Comms

katie.beach@inizioevoke.com

(937) 232-4889

**Investor Contact:**

Jim DeNike

MBX Biosciences

jdenike@mbxbio.com

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**MBX BIOSCIENCES, INC.**

**SELECTED FINANCIAL INFORMATION**

**Statements of Operations Data**

**(In thousands, except share and per share data)**

**(Unaudited)**

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three months ended June 30,** | **Three months ended June 30,** | **Six months ended June 30,** | **Six months ended June 30,** |
| **Condensed Statements of Operations Data:** | **2025** | **2024** | **2025** | **2024** |
| (in thousands, except per share and per share data) |  |  |  |  |
| Operating expenses |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | $17724 | $14396 | $40130 | $25445 |
| &nbsp;&nbsp;&nbsp;&nbsp;General and administrative | 4081 | 2262 | 8204 | 4527 |
| Total operating expenses | 21805 | 16658 | 48334 | 29972 |
| Loss from operations | (21805) | (16658) | (48334) | (29972) |
| Interest and other income, net | 2394 | 801 | 5043 | 1778 |
| &nbsp;&nbsp;&nbsp;&nbsp;Net loss | $(19411) | $(15857) | $(43291) | $(28194) |
| Net loss per common share, basic and diluted | $(0.58) | $(12.62) | $(1.30) | $(22.93) |
| Weighted average number of common shares <br> outstanding used in computation of net loss<br> per common share, basic and diluted | 33446385 | 1256549 | 33429479 | 1229473 |

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**Balance Sheet Data**

**(In thousands)**

**(Unaudited)**

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| | | |
|:---|:---|:---|
|  | **June 30,** | **December 31,** |
|  | **2025** | **2024** |
|  | **(in thousands)** | **(in thousands)** |
| **Condensed Balance Sheet Data:** |  |  |
| Cash, cash equivalents and marketable securities | $224906 | $262149 |
| Working capital<sup>(1)</sup> | 217434 | 256235 |
| Total assets | 231522 | 268535 |
| Total liabilities | 12283 | 11093 |
| Accumulated deficit | (180796) | (137505) |
| Total stockholders' equity | 219239 | 257442 |

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(1) Working capital is defined as total current assets less total current liabilities. See our financial statements and the related notes thereto included in our Quarterly Report on Form 10-Q for the Quarter Ended June 30, 2025 and our Annual Report on Form 10-K for the Year Ended December 31, 2024 for further details regarding our current assets and current liabilities.

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