MBX Biosciences (MBX) investor relations material

Canvuparatide in chronic hypoparathyroidism

• Phase III study began in Q4 after one-year AVAIL open-label extension data showed sustained clinical benefit; priorities include enrollment and confirmatory execution.

• Phase III is designed to confirm phase II findings over six months; key measures include response rate and urine calcium, relevant to kidney complications.

• Market research indicates patient preference for once-weekly over once-daily injections; the daily injectable competitor reached a $1.2B revenue run rate after six launch quarters.

• U.S. commercialization is viewed as manageable internally, with potential to commercialize outside the U.S. as well.

MBX 4291 obesity program

• Blinded phase I B1 data showed 7% weight loss at eight weeks (N=8; six active, two placebo); tolerability included one diarrhea episode.

• PK showed a gradual rise to peak concentration and sustained exposure, with a 26-day time to halve Cmax versus 21 days for Mounjaro; supports potential monthly dosing.

• C1 regimen: 30 mg weekly for four weeks, then 120 mg monthly and a further 180 mg monthly dose; 30 participants planned, 20 active and 10 placebo.

• Q4 disclosure is planned for C1; the target profile includes 6%-8% weight loss at 12 weeks, true monthly dosing and improved GI tolerability. A phase II launch is being prepared for 2027.

• Further clinical evidence of differentiation is viewed as a prerequisite to a potential obesity partnership; advancing into obesity phase III would require substantial capital.

Platform and financing

• PEP prodrug technology has clinical validation from Canvuparatide and early MBX 4291 data; development aims include once-monthly triple-G and multi-agonist obesity candidates.

• Preclinical data for MBX 6180 were slated for presentation at the upcoming ObesityWeek.

• Cash runway guidance extends into 2029; an additional roughly $100M on the balance sheet supports obesity phase II and Canvuparatide phase III programs.