Vicore Pharma (VICO) investor relations material

Recent updates and strategic focus

• Strong execution focus with a large phase II-B study in idiopathic pulmonary fibrosis (IPF) nearing enrollment completion in H1 2024.

• The company is advancing a novel AT2 receptor agonist, buloxibutid, targeting tissue repair and fibrosis resolution.

• Phase II-B trial expanded to 360 patients, powered to detect a 97 mL difference in lung function, aiming for best-in-class efficacy.

• Sufficient cash reserves ($130M at year-end) to fund operations through mid-2027 clinical readout and an additional year of Opex.

• Upcoming milestones include ATS conference data in May and a futility analysis later in 2024.

Clinical development and trial design

• Phase II-A AIR trial showed 65% of patients improved lung function over nine months, a rare outcome in IPF.

• Phase II-B ASPIRE trial allows enrollment with or without background standard of care, mirroring real-world use.

• Primary endpoint is 52-week change in FVC, aligning with regulatory standards for IPF therapies.

• Safety profile to date is favorable, with mild to moderate hair loss as the main side effect; no serious adverse events observed.

• Independent DSMB reviews have raised no safety concerns during ongoing enrollment.

Mechanistic differentiation and competitive landscape

• Buloxibutid promotes epithelial repair, addressing the root injury in IPF rather than just blocking fibrosis downstream.

• Mechanism is distinct from LPA1 and other antifibrotics, with potential for greater efficacy and safety.

• Tolerability is a key advantage, as current therapies have limited efficacy and significant side effects, leading to low uptake.

• The drug is positioned for use as frontline or in combination with standard of care, offering flexibility in treatment paradigms.

• Future expansion is considered for other fibrotic and inflammatory lung diseases, and possibly other organs.