MBX 8-K
MBX Biosciences, Inc. (MBX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
Securities registered pursuant to Section 12(b) of the Act:
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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.
Item 2.02. Results of Operations and Financial Condition.
On November 6, 2025, MBX Biosciences, Inc. (the "Company") announced its financial results for the quarter ended September 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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Resignation of Director
On October 31, 2025, James M. Cornelius, a member of the Company’s board of directors (the “Board”) and the chairperson of the audit committee of the Board (the “Audit Committee”), resigned from the Board, including from his role on any committees, effective immediately. Mr. Cornelius’s resignation from the Board was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
Designation of Executive Chairman of the Board of Directors
On November 3, 2025, Steven Hoerter, a current member of the Board, was appointed to serve as executive chairperson of the Board, effective as of November 6, 2025. As executive chairperson, he will be responsible for the effective performance of the Board and will work closely with Mr. Hawryluk in an advisory capacity.
Mr. Hoerter’s biographical information is set forth in the Company’s Definitive Proxy Statement (the “Proxy Statement”) filed with the Securities and Exchange Commission (the “SEC”) on April 22, 2025, and such information is incorporated herein by reference.
Mr. Hoerter will receive the compensation set forth in the Company’s non-employee director compensation policy for service in the role of chairperson, and will be granted an option to purchase 100,000 shares of the Company’s common stock, to vest in equal monthly installments over a one-year period, commencing on the grant date, subject to the director’s continuous service with the Company on each applicable vesting date. The stock options shall have an exercise price equal to the closing price of the Company’s common stock as reported by the Nasdaq Global Select Market on the grant date. Mr. Hoerter’s compensatory arrangements as a member of the Board are disclosed in Proxy Statement and such information is incorporated herein by reference. As part of Mr. Hoerter’s appointment, the board of directors has confirmed that Mr. Hoerter continues to satisfy the relevant independence requirements for service on the Audit Committee set forth in the rules of the SEC and the Nasdaq listing rules. There are no arrangements or understandings between Mr. Hoerter and any other persons pursuant to which he was appointed as executive chairperson of the Company.
Appointments of Directors and Board Committee Assignments
Effective as of October 31, 2025, the Board appointed Ed Mathers, a current member of the Board, to the Audit Committee vacancy created by Mr. Cornelius’s resignation, and appointed Tiba Aynechi, a current member of the Board and of the Audit Committee, to serve as the chairperson of the Audit Committee in lieu of Mr. Cornelius. Following such appointments, the Audit Committee is comprised of Ms. Aynechi, as chairperson, Mr. Hoerter, and Mr. Mathers.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit No. |
Description |
99.1 |
Press Release Issued by MBX Biosciences, Inc. on November 6, 2025 |
104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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. |
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Date: |
November 6, 2025 |
By: |
/s/ P. Kent Hawryluk |
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President and Chief Executive Officer (Principal Executive Officer) |
Exhibit 99.1
MBX Biosciences Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights
Reported positive topline results from the Phase 2 Avail™ trial of once-weekly canvuparatide in hypoparathyroidism (HP)
Completed upsized public offering, raising approximately $200 million in gross proceeds
$391.7 million in cash, cash equivalents and marketable securities as of September 30, 2025; expected to support operations into 2029
Updated 2026 corporate milestones include clinical data for three Precision Endocrine Peptide™ (PEP) programs and initiation of a Phase 3 trial in HP.
CARMEL, Ind., November 6, 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 third quarter ended September 30, 2025, and highlighted recent corporate progress.
“The third quarter of 2025 marked another quarter of significant execution as we reported positive topline results from our Phase 2 Avail™ trial of once-weekly canvuparatide,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “These strong results support our belief that canvuparatide has the potential to be best-in-class in hypoparathyroidism, an estimated multibillion dollar market. We are preparing for meetings with US and EU regulatory agencies, initiation of our Phase 3 trial and future commercialization. With a clinically validated PEP™ platform, and cash runway into 2029, MBX is well positioned to execute on our value-creating milestones in 2026 across our pipeline and become a leading, fully integrated endocrine and metabolic disease biopharma company.”
In November 2025, the Company's board of directors appointed Steve Hoerter to serve as executive chairperson, to support the Company’s executive team with his perspective and commercialization experience, as the Company prepares for the start of a Phase 3 trial and begins pre-commercial activities. Mr. Hoerter joined the Company’s board of directors earlier this year, bringing more than 30 years of pharmaceutical commercialization and executive leadership experience, most recently as President and Chief Executive Officer of Deciphera Pharmaceuticals until its $2.4 billion acquisition by Ono Pharmaceutical in 2024. Jim Cornelius also retired from the board as of October 31, 2025, after more than five years of valuable service.
Third Quarter 2025 and Recent Corporate Highlights
Hypoparathyroidism (HP): Canvuparatide (MBX 2109)
Obesity: MBX 4291
Post-bariatric Hypoglycemia (PBH): Imapextide (MBX 1416)
Corporate
Anticipated Milestones
Third Quarter 2025 Financial Results
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) preparing for Phase 3 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 www.mbxbio.com and follow it on LinkedIn.
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 trial of canvuparatide, including timing of results from the open-label extension and timing of initiation of a Phase 3 trial; the potential for canvuparatide to be a best-in-class, once-weekly PTH replacement therapy; the expected timing of results from the Phase 2a trial for imapextide; statements related to the ability of imapextide to be a treatment of PBH; the expected timing of results from the 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 September 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 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:
Cassidy McClain
Inizio Evoke Comms
[email protected]
(619) 694-6291
Investor Contact:
Jim DeNike
MBX Biosciences
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 September 30, |
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Nine months ended September 30, |
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Condensed Statements of Operations Data: |
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2025 |
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2024 |
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2025 |
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2024 |
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(in thousands, except per share and per share data) |
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Operating expenses |
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Research and development |
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$ |
19,270 |
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$ |
16,747 |
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$ |
59,400 |
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$ |
42,192 |
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General and administrative |
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4,656 |
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2,865 |
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12,860 |
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7,392 |
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Total operating expenses |
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23,926 |
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19,612 |
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72,260 |
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49,584 |
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Loss from operations |
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(23,926 |
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(19,612 |
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(72,260 |
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(49,584 |
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Interest and other income, net |
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2,308 |
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1,470 |
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7,351 |
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3,248 |
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Net loss |
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$ |
(21,618 |
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$ |
(18,142 |
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$ |
(64,909 |
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$ |
(46,336 |
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Net loss per common share, basic and diluted |
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$ |
(0.63 |
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$ |
(2.78 |
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$ |
(1.93 |
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$ |
(15.42 |
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Weighted average number of common shares |
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34,198,597 |
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6,515,616 |
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33,688,669 |
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3,004,382 |
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Balance Sheet Data
(In thousands)
(Unaudited)
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September 30, |
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December 31, |
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2025 |
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2024 |
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(in thousands) |
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Condensed Balance Sheet Data: |
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Cash, cash equivalents and marketable securities |
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$ |
391,673 |
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$ |
262,149 |
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Working capital(1) |
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385,440 |
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256,235 |
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Total assets |
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400,076 |
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268,535 |
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Total liabilities |
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12,538 |
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11,093 |
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Accumulated deficit |
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(202,414 |
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(137,505 |
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Total stockholders’ equity |
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387,538 |
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257,442 |
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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 September 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.