One-year data demonstrated sustained benefit of once-weekly canvuparatide as a potential PTH replacement therapy in chronic hypoparathyroidism; Phase 3 pivotal trial now recruiting
Initial Phase 1 data for MBX 4291, a GLP-1/GIP co-agonist prodrug for obesity, support potential for once-monthly dosing; data from 12-week MAD (Part C) on track for Q4 2026
Nomination of development candidate MBX 6180, a GLP-1/GIP/GCG triple agonist prodrug designed for once-monthly dosing, further expands obesity portfolio
$418.6 million in cash and investments expected to support operations into 2029
CARMEL, Ind. and BURLINGTON, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today reported financial results for the second quarter ended June 30, 2026, and highlighted recent corporate progress.
"The second quarter was highlighted by important milestones across our pipeline, including a first look at clinical data for MBX 4291 supporting its potential for true once-monthly dosing in obesity," said Steve Hoerter, Chairman and Chief Executive Officer of MBX Biosciences. "In addition, we were proud to present the full Phase 2 and one-year OLE data for once-weekly canvuparatide, which demonstrated sustained benefit and the potential to become a best-in-class treatment for patients with chronic hypoparathyroidism. Now we look forward to dosing the first patients in our Phase 3 trial of canvuparatide this quarter and to presenting 12-week multiple ascending dose (MAD) data for MBX 4291 in the fourth quarter. With a strong balance sheet and an experienced team, we continue to leverage our proprietary PEP$(TM)$ platform to develop differentiated, long-acting peptide therapies with the potential to meaningfully improve patients' lives."
Second Quarter 2026 and Corporate Highlights
Once-Weekly Canvuparatide for Hypoparathyroidism $(HP)$
-- Full Phase 2 results and one-year OLE data presented at ENDO 2026:
Results demonstrated sustained benefit of once-weekly canvuparatide as a
potential PTH replacement therapy through one year, with findings
consistent with restoration of systemic PTH activity through
normalization of serum calcium, reduction of urine calcium excretion and
restoration of bone metabolism, as well as a safety profile and
pharmacokinetics supporting once-weekly dosing.
-- Phase 3 trial of once-weekly canvuparatide now recruiting: MBX remains on
track to initiate a Phase 3 pivotal trial of once-weekly canvuparatide in
chronic hypoparathyroidism in Q3 2026. Clinical trial sites have been
activated, and participants are currently being recruited and screened.
The oPTimize Phase 3 pivotal, global, multicenter, randomized,
double-blind placebo-controlled study will evaluate the safety,
pharmacokinetics and efficacy of once-weekly canvuparatide in patients
with HP.
MBX 4291 and Expanding Obesity Portfolio
-- Initial Phase 1 data for MBX 4291 supports potential for once-monthly
dosing: Preliminary blinded data from the ongoing Phase 1 trial of MBX
4291, a dual GLP-1/GIP receptor agonist peptide prodrug, in adults with
obesity demonstrated mean weight loss of 7% (range, 0--16%) at eight
weeks (n=8, including 2 placebo) in the first multiple ascending dose
(MAD) Part B cohort, with MBX 4291 generally well tolerated through eight
weeks. The Company remains on track to report data from the first cohort
of the 12-week MAD (Part C) in Q4 2026. Cohort C1 is evaluating a 30 mg
(once-weekly x 4) + 120 mg (once-monthly) + 180 mg (once-monthly)
titration regimen in adult participants with obesity (BMI >= 30).
-- Nomination of MBX 6180 as GLP-1/GIP/GCG triple agonist prodrug
development candidate: The Company today announced nomination of MBX 6180
as its lead GLP-1/GIP/glucagon (GCG) triple agonist prodrug candidate,
further expanding its obesity pipeline to potentially address the full
spectrum of patient needs. MBX 6180 combines GLP-1, GIP and GCG receptor
agonist activity in a single construct. The differentiated design of MBX
6180 is intended to provide a pharmacokinetic profile supporting
once-monthly dosing. The Company expects to present preclinical data from
MBX 6180 at a scientific meeting in the fourth quarter of 2026.
IND-enabling studies are now underway.
-- Nomination of MBX 5765 as amycretin prodrug development candidate: In May
2026, MBX nominated MBX 5765 as its lead amycretin prodrug development
candidate. Enabled by the Company's proprietary PEP(TM) platform, MBX
5765 combines GLP-1, GIP, GCG, and dual amylin and calcitonin receptor
agonist (DACRA) activity in a single peptide construct. The
differentiated mechanism of MBX 5765 is designed for once-monthly dosing,
superior efficacy and improved tolerability. IND-enabling studies are
ongoing.
Corporate
-- Executive Appointments to Support Next Phase of Growth: Steve Hoerter,
current Executive Chairman of the MBX Board, was appointed Chairman and
Chief Executive Officer, succeeding Kent Hawryluk. Mr. Hoerter joined the
MBX Board of Directors in April 2025 and was appointed Executive Chairman
in November 2025. In addition, John Smither, previously the Interim Chief
Financial Officer, was appointed as Chief Financial Officer.
Anticipated Milestones
Canvuparatide
-- Q3 2026: Initiation of pivotal Phase 3 oPTimize trial
MBX 4291
-- Q4 2026: Results from the first cohort of the 12-week MAD (Part C)
portion of the ongoing Phase 1 trial
Second Quarter 2026 Financial Results
-- Cash and Cash Equivalents and Marketable Securities: As of June 30, 2026,
MBX had cash, cash equivalents and marketable securities of $418.6
million. Based on its current operating plan, the Company expects the
combined cash, cash equivalents and marketable securities balance to fund
operations into 2029.
-- R&D Expenses: Research and development expenses for the three months
ended June 30, 2026, were $31.0 million, compared to $17.7 million for
the same period in 2025. The increase of $13.3 million was driven by an
increase in start-up costs related to the canvuparatide Phase 3 clinical
trial, ongoing conduct of the canvuparatide Phase 2 open-label extension
clinical trial, ongoing conduct of the MBX 4291 Phase 1 clinical trial
and timing of preclinical activities related to MBX 5765.
-- G&A Expenses: General and administrative expenses for the three months
ended June 30, 2026, were $9.9 million, compared to $4.1 million for the
same period in 2025. The increase of $5.9 million was driven by higher
personnel-related costs (including stock-based compensation) resulting
from continued expansion of both our executive leadership team and
general infrastructure to support growth in our operations
-- Net Loss: Net loss for the three months ended June 30, 2026, was $37.1
million compared to a net loss of $19.4 million for the same period in
2025.
About MBX Biosciences
MBX Biosciences is a biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies based on its proprietary PEP(TM) 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 in Phase 3 development; and an obesity portfolio that includes MBX 4291 in Phase 1 development and MBX 5765 and MBX 6180 in preclinical development, as well as additional discovery candidates. The Company is based in Carmel, Indiana and Burlington, Massachusetts. 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(TM)) 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(TM) (PEP(TM)) 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
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