CiVi Biopharma

Phase 3

Chevy Chase, United StatesFounded 2017civibio.com

CiVi Biopharma Holding Corp. is a clinical-stage R&D biotech founded in 2017 with a mission to create novel cardiovascular and metabolic therapies. The company leverages antisense oligonucleotide technology, with a pipeline featuring an intravenous therapy for severe frostbite (in Phase 3) and a next-generation oral PCSK9 inhibitor in pre-clinical development. Led by an experienced team with deep cardiovascular and RNA therapeutics expertise, CiVi aims to address significant unmet needs in lipid management and orphan diseases.

Founded

2017

Focus

RNA & Gene Therapy

AI Company Overview

Technology Platform

Focus on creating novel oral antisense oligonucleotide (ASO) therapies, aiming to overcome delivery challenges to enable patient-friendly oral dosing for chronic conditions.

Funding History

Total raised: $30M

Series A$25MUndisclosedNov 15, 2022

Seed$5MUndisclosedJun 15, 2021

Opportunities

Major opportunity lies in developing the first effective oral PCSK9 inhibitor, which could capture a large share of the multi-billion dollar lipid management market due to superior convenience.

The frostbite program addresses a clear unmet need in an orphan disease with no approved pharmacologic treatments, offering a faster path to a focused commercial opportunity.

Risk Factors

High technical risk associated with developing a bioavailable and effective oral antisense oligonucleotide, a challenge that has eluded the field.

Clinical risk remains for the Phase 3 frostbite trial.

As a private, pre-revenue company, it faces significant financing risk to advance its capital-intensive pipeline.

Competitive Landscape

CiVi 008 faces intense competition from established injectable PCSK9 inhibitors (mAbs like Repatha/Praluent and siRNA Leqvio), but its proposed oral formulation is a key differentiator in a market dominated by injectables. For CiVi 030, competition is essentially the current standard of care (supportive/surgical), as there are no approved pharmacologic therapies for severe frostbite.