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BridgeBio Pharma (BBIO) investor relations material

BridgeBio Pharma Investor Update summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Investor Update summary10 Sep, 2025

Disease Overview and Patient Experience

  • ADH1 is a rare, autosomal dominant disorder caused by activating variants in the calcium-sensing receptor (CASR), leading to hypocalcemia, low or suppressed PTH, and high urinary calcium, with significant neuromuscular and renal complications.

  • Standard care with calcium and vitamin D supplementation often fails to correct the underlying pathophysiology and may worsen long-term renal complications.

  • ADH1 is frequently underdiagnosed, with a median age of genetic confirmation at 25 years and a prevalence of about 1 in 25,000.

  • Genetic testing is crucial for definitive diagnosis and family screening.

  • Patient stories highlight the burden of disease, frequent monitoring, and the hope for targeted therapies.

Unmet Need

  • No therapies are specifically indicated for ADH1, representing a significant unmet need.

Incalerit/Encaleret Mechanism and Clinical Development

  • Incalerit/Encaleret is an investigational oral calcilytic that acts as a negative allosteric modulator of the CaSR, aiming to restore PTH secretion, normalize blood calcium, and reduce urinary calcium.

  • Phase II/2 studies in 13 patients showed robust, sustained normalization of blood and urine calcium and PTH over 42 months, with a favorable safety profile and most adverse events being mild or moderate and transient.

  • Nearly 69% of patients achieved both blood and urine calcium in the normal range, a result not seen with standard care.

  • The ongoing Phase III CALIBRATE study is a randomized, controlled trial enrolling 71 participants aged 16 and older, with a primary endpoint of achieving target blood and urine calcium at 24 weeks; topline results are expected in Fall 2025.

  • Secondary endpoints include PTH, vitamin D, magnesium, phosphate, renal function, and quality of life.

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Frequently asked questions

BridgeBio Pharma, Inc. engages in the discovery, development, and delivery of various medicines for genetic diseases. The company's lead candidates for the treatment of Fabry disease comprise a pipeline of recombinant enzyme-replacement therapies comprising elaprase and lysosomal-phospholipid-glycoprotein (PLG) analogs. It focuses on developing therapeutics for treating Fabry disease, a rare genetic disorder characterized by progressive loss of kidney function and the buildup of fatty substances that damage blood vessels and organs. BridgeBio Pharma, Inc.i s based in Waltham, Massachusetts.

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