MBX Biosciences : Company Overview - May 2026

Published: 2026-05-07 08:27:28 ET MBX

Published on 05/07/2026 at 08:27 am EDT

May 2026

Pioneering Precision Peptides for Endocrine and Metabolic Diseases

May 2026

MBX: Catalyst-Rich Year Ahead

Program

Milestone

Anticipated Timing

Canvuparatide (MBX 2109)

End-of-Phase 2 FDA Meeting

Avail Phase 2 presentation and one-year OLE data

ENDO 2026

Phase 3: Initiation

Q3 2026

MBX 4291 (GLP-1/GIP)

Phase 1: 12-week MAD results

Q4 2026

MBX 5XXX (amycretin)

Nominate development candidate

Q2 2026

MBX 6XXX (GLP-1/GIP/GCGR)

Nominate development candidate

Q3 2026

Imapextide (MBX 1416)

STEADI Phase 2a: Results

Q2 2026

$440 million in cash provides runway into 20291

1 Unaudited cash and investments as of March 31, 2026

World Class Leadership Team

Kent Hawryluk

President & CEO

Sam Azoulay, MD

Chief Medical Officer

Karen Basbaum

Chief Business Officer

Michelle Graham

Chief Human Resource Officer

Mark Soued

Chief Commercial Officer

Chatan Charan, PhD

Senior Vice President,

Pharmaceutical Development & CMC

Pete De Spain Senior Vice President, Investor Relations &

Corporate Communications

Mike Dorato, PhD Senior Vice President, Discovery & Non-Clinical Development

Mark Hope Senior Vice President, Regulatory & Quality

Andreas Moraitis, MD Senior Vice President, Clinical Development

Clinically Validated Precision Endocrine Peptide (PEP ) Platform

Created by MBX and Scientific Founder Richard DiMarchi, PhD

INNOVATIVE PEPTIDE DESIGN

With a goal to optimize:

Multiple mechanisms of action within a single peptide

Increased potency

Enhanced physical properties, including stability and solubility

PROGRAMMABLE PRODRUG

Designed to provide:

Gradual, controlled release of active drug

Slow rise to maximum

exposure

Flattened exposure

FATTY ACYLATION

With a goal to optimize:

Longer time action

More convenient dosing

Combining PEP technologies to deliver differentiated and best-in-class medicines for patients

Investigational Once-Weekly PTH Replacement Therapy for Hypoparathyroidism

Chronic Hypoparathyroidism: A Serious Endocrine Disease

Affecting More than 250,000 Patients in the U.S. and Europe

Conventional therapy includes large and frequent doses of calcium and active vitamin D

Majority of patients are insufficiently managed and may experience:

Cramps

Fatigue

Seizures

Anxiety or depression

Long-term complications including kidney stones and chronic kidney disease

Source:Mannstadt M, et al. Nat Rev Dis Primers. 2017;3:17055. Vadiveloo T, et al. J Bone Miner Res. 2018;33(3):478-485. Clarke BL, et al. J Clin Endocrinol Metab. 2016;101(6):2284-99. Powers J, et al. J Bone Miner Res. 2013;28(12):2570-6. Underbjerg L, et al. J Bone Miner Res. 2013;28(11):2277-85. Soibelman D, Ronen O. Clin Otolaryngol. 2025;50(2):205-219. Cianferotti L, et al. Calcif Tissue Int. 2018;103(2):144-150. Swartling O, et al. J Clin Endocrinol Metab. 2022;107(10):e4098-e4105.

Canvuparatide Data Support Potential Best-in-Class Profile

for Hypoparathyroidism

Responder Rate at Week 12 in Avail*

*Statistically significant vs. placebo

Responder Rate at 6 Months in OLE1

•

All patients completed the 12-week Avail trial and 94% entered the 2-year open-label extension (OLE)

Once-weekly canvuparatide was well tolerated, with no treatment-related serious adverse events

or discontinuations during the 12-week trial

96% of responders at Week 12 remained responders at 6 months2

Initiation of Phase 3 trial anticipated in Q3 2026

1 Analysis based on patients with available data for each component of the composite criteria, defined as independence from active vitamin D, independence from oral calcium (≤600 mg/day),

and serum AdjCa within the normal range (8.2-10.6 mg/dL) at 6 months.

2 Based on patients with available data (23 out of 24)

Once-Weekly Dosing Drives Preference for HCPs and HP Patients

of Endocrinologists

chose once-weekly over daily

90%

of Nurses

chose once-weekly over daily

100%

of HP Patients

chose once-weekly over daily

of endocrinologists said they would be

"extremely likely" to switch from daily to once-weekly if it were approved/available

HP = Hypoparathyroidism

Source: Primary US market research study (n=10 endocrinologists, n=10 nurses responsible for injection training and initiation, n=20 HP patients); conducted by Bold Insight; August - September 2024; assumes otherwise same product profile

Phase 3 Trial Design and Endpoints for Once-Weekly Canvuparatide

26-Week Double-blind Placebo-Controlled Trial followed by a 78-Week Open-Label Extension

Treatment Period: 26 weeks Open-Label Extension: 78 weeks

4- Week Fixed Dose Treatment Period

18-Week Dose

Adjustment Period

4-Week Dose Maintenance Period

8 Week Screen & Optimization

3:1

N=160

600 μg Canvuparatide QW (n=120)

Placebo (n=40)

Titrate Canvuparatide

Titrate Placebo

No Study Drug Titration

Continuation of QW Canvuparatide (n=120)

Primary Endpoint Week 26

Placebo Crossover: Canvuparatide (n=40)

day Follow-up

Phase 3 Trial Endpoints

Planned Primary Composite Endpoint (Week 26)

Proportion of patients (% responders) meeting all four criteria:

Normal albumin-adjusted serum calcium (8.3 mg/dL to 10.6 mg/dL)

Independence from active vitamin D

Calcium supplements (<600 mg/day)

No increase in dose of canvuparatide during last 4 weeks

Planned Key Secondary Endpoints

Normalization of urine calcium excretion in patients with elevated

values at baseline while normalizing serum calcium

Patient reported outcomes (PROs)

QW = once weekly

Once-Weekly Canvuparatide: Paving the Way for a Potential New Standard of Care in Hypoparathyroidism

Significant milestones upcoming, including

one-year follow-up data at ENDO in June 2026

Phase 3 trial preparations underway, initiation

anticipated in Q3 2026

Chief Commercial Officer on board, commercial readiness preparation ongoing

MBX retains global commercial rights, patent protection to 2041 and beyond

Obesity Opportunity: Once-Monthly Dosing with Improved Tolerability

MBX obesity candidates are designed using proprietary PEP platform for once-monthly dosing

with the goal of more gradual, flattened and sustained exposure and improved tolerability

1,000

Concentration (ng/mL)

100

T1/2Cmax > 21 days

T1/2Cmax ~ 20 to 21 days

T1/2Cmax ~ 5 to 6 days

0 7 14 21 28 35

Time (days)

Tirzepatide

MET-097i (GLP-1 Monoagonist)

Source for tirzepatide concentrations: CPT Pharmacometrics Syst Pharmacol. 2024 Mar;13(3):494-503. Tirzepatide is the active ingredient in Zepbound. Source for MET-0971i concentrations: Metsera, Inc. Form S-1, filed January 10, 2025.

T1/2Cmax calculated as time to 50% of Cmax

Pipeline Designed to Address Broad Range of Obesity Patient Needs

MBX 4291

GLP-1/GIP Agonist

Weight loss with

improved tolerability

Improved convenience

MBX 5XXX

Amycretin

Significant weight loss

Muscle preservation

Differentiated mechanism of action

Improved convenience

MBX 6XXX GLP-1/GIP/GCGR

Agonist

Significant weight loss

Differentiated mechanism of action

Improved convenience

MBX is developing a robust obesity portfolio with potential to drive strong optionality across patient segments

MBX 4291: Engineered for Gradual Release, Long Exposure and

Dual GLP-1/GIP Agonism

MBX scientific founder,

Richard DiMarchi, PhD

MBX 4291 Proof of Concept: Flattened and Steady Exposure

Week 1 Week 4

MeCanonCcoenncternattrioatnio(nμM(µ)M)

0.1

0.01

0.001

1 2 3 4 5 6 7 8

22 23 24 25 26 27 28 29

Time (Days)

0.4323 mg/kg MBX 4291 (Active)

1.33 mg/kg MBX 4291 (Active)

4.33 mg/kg MBX 4291 (Active)

13.3 mg/kg MBX 4291 (Active)

Once-weekly dosing in non-human primates

MBX 4291 Ongoing Phase 1 Trial

SAD (Part A)

MAD (Part B)

MAD (Part C)

Participants

BMI > 30

Design

N=40

N=24

N=30

5 Cohorts

3 Cohorts

1 Cohort1

X X X

MBX 4291

N=6

N=20

N=2

N=10

Single dose (15 mg to 180 mg) 4 weekly doses Weekly dosing followed by once monthly dosing

for 12 weeks

Endpoints

Primary:

Establish safety and tolerability focusing on competitive gastrointestinal tolerability and streamlined dose titration

Secondary:

Determine pharmacokinetics suitable for monthly injection schedule

Demonstrate pharmacodynamics (i.e., weight loss)

Identify doses and titration regimen for Phase 2

1 May add a second cohort to evaluate additional doses/dosing regimens

New Development Candidates Aimed at Exciting Obesity Targets

Amycretin

Nomination Q2 2026

GLP-1/GIP/GCGR

Nomination Q3 2026

Designed to address full spectrum of disease, each with once-monthly dosing

Single dose administration evaluated by MBX in an in vivo model in non-human primates (NHPs); Represents active drug concentrations

Imapextide (MBX 1416)

Long-Acting GLP-1 Receptor Antagonist for Post-Bariatric Hypoglycemia

Post-Bariatric Hypoglycemia (PBH): A Rare, Serious and Chronic Complication of Bariatric Surgery

Estimated >125,000 patients in U.S.1,2,3,4

CAUSE1,2

Rapid transit of nutrients into intestines stimulates excess GLP-1 and insulin secretion; occurs after a meal

PBH presents six months to years after roux-en-Y gastric bypass and sleeve gastrectomy

SYMPTOMS

Severe Hypoglycemia

Neuroglycopenia symptoms including seizures, loss of consciousness, confusion, weakness, dizziness and blurred vision

PATIENT IMPACT

Unpredictable timing and

frequency

Social isolation

Diminished quality of life, including disability

Glucagon injection may be required

1. Fischer et al Surg Obes Relat Dis. 2021, 2. Michaels et al Obes Surg. 2017, 3. Lee et al Obesity 2015, 4. Internal Estimates

2026

Disclaimer

MBX Biosciences Inc. published this content on May 07, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 07, 2026 at 12:26 UTC.