MBX Biosciences, Inc 8-K, filed May 12, 2025
MBX Biosciences, Inc. (MBX)
About this 8-K
MBX Biosciences, Inc filed this 8-K on May 12, 2025.
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
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
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
(Former Name or Former Address, if Changed Since Last Report)
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:
|
|
Trading |
|
|
|
|
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 May 12, 2025, MBX Biosciences, Inc. (the "Company") announced its financial results for the quarter ended March 31, 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.
|
|
Exhibit No. |
Description |
99.1 |
Press Release Issued by MBX Biosciences, Inc. on May 12, 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.
|
|
|
MBX Biosciences, Inc. |
|
|
|
|
Date: |
May 12, 2025 |
By: |
/s/ P. Kent Hawryluk |
|
|
|
President and Chief Executive Officer (Principal Executive Officer) |
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
Investigational New Drug submission for MBX 4291 on track for 2Q 2025
$240.8 million in cash, cash equivalents and marketable securities as of March 31, 2025; expected to support operations into mid-2027
CARMEL, Ind., May 12, 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 first quarter ended March 31, 2025, and highlighted recent corporate progress.
“We’ve followed up on our strong execution in 2024 with excellent progress on all our programs enabled by a strong balance sheet and cash position,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “Following full enrollment of the Phase 2 Avail trial investigating canvuparatide for the treatment of hypoparathyroidism, we look forward to reporting top line results in the third quarter of 2025. We’re also on track to submit our investigational new drug (IND) application this quarter for MBX 4291, a novel glucagon-like peptide 1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) co-agonist prodrug for treating obesity. In addition to these milestones, we also expect to begin a Phase 2 trial for MBX 1416 in post-bariatric hypoglycemia patients in the second half of this year and share further details on our additional obesity candidates currently in pre-clinical development.”
First Quarter 2025 and Recent Corporate Highlights
Hypoparathyroidism (HP): Canvuparatide (MBX 2109)
Obesity: MBX 4291
Post-bariatric Hypoglycemia (PBH): MBX 1416
Corporate
First 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) in Phase 2 development; MBX 1416 for the treatment of post-bariatric hypoglycemia (PBH) in Phase 1 development; and an obesity portfolio that includes MBX 4291, with an IND filing anticipated in Q2 2025, 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 Avail™ trial of canvuparatide, including the timing of topline results; the expected timing of the IND application submission for MBX 4291; statements related to MBX 2491 being developed as a once-monthly treatment for obesity; expectations regarding development of MBX Biosciences’ additional obesity candidates currently in pre-clinical development; the expected timing for the Phase 2 trial for MBX 1416 in PBH patients; statements related to the ability of MBX 1416 to be a treatment of PBH; statements related to the contribution of MBX Biosciences’ leadership and board of directors; 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 March 31, 2025 filed with the Securities and Exchange Commission (SEC), its Annual Report on Form 10-K for the year ended December 31, 2024 filed with the 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:
Katie Beach Oltsik
Inizio Evoke Comms
katie.beach@inizioevoke.com
(937) 232-4889
Investor Contact:
Jim DeNike
MBX Biosciences
jdenike@mbxbio.com
MBX BIOSCIENCES, INC.
SELECTED FINANCIAL INFORMATION
Statements of Operations Data
(In thousands, except share and per share data)
(Unaudited)
|
|
Three months ended March 31, |
|
|||||
Condensed Statements of Operations Data: |
|
2025 |
|
|
2024 |
|
||
(in thousands, except per share and per share data) |
|
|
|
|
|
|
||
Operating expenses |
|
|
|
|
|
|
||
Research and development |
|
$ |
22,405 |
|
|
$ |
11,049 |
|
General and administrative |
|
|
4,124 |
|
|
|
2,265 |
|
Total operating expenses |
|
|
26,529 |
|
|
|
13,314 |
|
Loss from operations |
|
|
(26,529 |
) |
|
|
(13,314 |
) |
Interest and other income, net |
|
|
2,649 |
|
|
|
977 |
|
Net loss |
|
$ |
(23,880 |
) |
|
$ |
(12,337 |
) |
Net loss per common share, basic and diluted |
|
$ |
(0.71 |
) |
|
$ |
(10.26 |
) |
Weighted average number of common shares |
|
|
33,412,386 |
|
|
|
1,202,396 |
|
Balance Sheet Data
(In thousands)
(Unaudited)
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
2024 |
|
||
|
|
(in thousands) |
|
|||||
Condensed Balance Sheet Data: |
|
|
|
|
|
|
||
Cash, cash equivalents and marketable securities |
|
$ |
240,786 |
|
|
$ |
262,149 |
|
Working capital(1) |
|
|
233,795 |
|
|
|
256,235 |
|
Total assets |
|
|
245,926 |
|
|
|
268,535 |
|
Total liabilities |
|
|
10,504 |
|
|
|
11,093 |
|
Convertible preferred stock |
|
|
— |
|
|
|
— |
|
Accumulated deficit |
|
|
(161,385 |
) |
|
|
(137,505 |
) |
Total stockholders’ equity |
|
|
235,422 |
|
|
|
257,442 |
|
(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 Three Months Ended March 31, 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.