What PhaseBio Pharmaceuticals does

PhaseBio Pharmaceuticals is a clinical-stage biopharmaceutical company headquartered in Malvern, Pennsylvania (with an additional administrative office in San Diego, California) that develops novel therapies for cardiovascular and cardiopulmonary diseases. The company's lead asset is bentracimab (PB2452), a recombinant human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of ticagrelor in patients experiencing major bleeding or requiring urgent surgery; it is currently in Phase 3 development under FDA Breakthrough Therapy Designation and has demonstrated more than 90% good-or-excellent hemostasis efficacy in interim analysis. The pipeline additionally includes PB6440, an oral highly selective aldosterone synthase inhibitor for treatment-resistant hypertension with an IND submission targeted for the second half of 2022, while pemziviptadil (PB1046), a once-weekly VIP analogue for pulmonary arterial hypertension, was voluntarily discontinued in December 2021 due to COVID-19-related manufacturing and enrollment disruption. The technology foundation is PhaseBio's proprietary elastin-like polypeptide (ELP) platform, which enables less-frequent dosing and improved pharmacokinetics across pipeline programs.

PhaseBio currently generates no product revenue and recorded a net loss of $131.1 million against $41.8 million of cash and cash equivalents at year-end 2021, with R&D expense of $102.1 million. Capital has been sourced through an October 2018 IPO on Nasdaq (ticker PHAS), a March 2021 underwritten public offering of 18.4 million shares at $3.50 per share (approximately $60.2 million net proceeds), a financing and co-development agreement with SFJ Pharmaceuticals (up to $120 million, with $91.3 million funded through December 2021), and an exclusive European licensing deal with Alfasigma S.p.A. ($20 million upfront plus up to $245 million in milestones plus tiered royalties). The company is building a U.S. critical-care focused commercial organization under a newly hired Chief Commercial Officer in preparation for a planned mid-2022 BLA submission, with planned direct hospital-channel distribution in the U.S. and partner-led commercialization in Europe (Alfasigma) and China (SFJ). End customers are hospitals, emergency rooms, trauma centers, and surgical facilities treating patients on ticagrelor who experience major bleeding or require urgent surgery.

Name

PhaseBio Pharmaceuticals

Legal name

PhaseBio Pharmaceuticals, Inc.

Website

https://phasebio.com

Company type

Public

Founded year

2014

Operating status

Operating

Headcount range

51–100 employees

Short description

PhaseBio Pharmaceuticals is a clinical-stage biopharmaceutical company developing bentracimab, a first-in-class ticagrelor reversal agent, and PB6440 for resistant hypertension, using its proprietary elastin-like polypeptide (ELP) technology platform to address cardiovascular unmet needs.

Ownership category

akta.pro rank

Product category

Cardiovascular Biopharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Cardiology & Vascular Specialty Pharmaceuticals (HLAIACAG)

akta.pro secondary industries

Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE), Translational Medicine & Biomarkers (HLAIALAF)

Keywords

• Cardiovascular therapeutics
• Antiplatelet reversal agents
• Biopharmaceutical drug development
• Pulmonary arterial hypertension
• Resistant hypertension treatment

Headquarters

HQ city

Malvern

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Product Revenue (Future): PhaseBio is a clinical-stage biopharmaceutical company that does not currently generate product revenue. The company is preparing for commercialization of bentracimab, its lead product candidate. The company plans to commercialize bentracimab in the U.S. market upon FDA approval, targeting mid-2022 BLA submission.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels7 records

Core offering

PhaseBio is a clinical-stage biopharmaceutical company developing novel therapies for cardiovascular and cardiopulmonary diseases. Its lead product candidate, bentracimab (PB2452), is a recombinant human monoclonal antibody Fab fragment intended to reverse the antiplatelet activity of ticagrelor in patients with major bleeding or those needing urgent surgery. Earlier-stage assets include the discontinued pemziviptadil (PB1046) once-weekly VIP analogue for PAH and PB6440, an oral aldosterone synthase inhibitor in development for resistant hypertension.

Product overview

PhaseBio Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapies for cardiovascular and cardiopulmonary diseases. The company's pipeline centers on three main product candidates: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor currently in Phase 3 development; pemziviptadil (PB1046), a once-weekly VIP receptor agonist for pulmonary arterial hypertension (now discontinued); and PB6440, an oral aldosterone synthase inhibitor for resistant hypertension in pre-clinical development. The proprietary elastin-like polypeptide technology platform enables therapies with improved pharmacokinetics and less frequent dosing. PhaseBio is headquartered in Malvern, PA, and San Diego, CA.

Differentiator

Problem solved

Functional benefit

Products and services

• Bentracimab (PB2452) A novel, recombinant, human monoclonal antibody antigen-binding fragment (Fab fragment) designed to reverse the antiplatelet activity of ticagrelor in patients presenting with uncontrolled bleeding or requiring surgery, currently in late-stage Phase 3 development with FDA Breakthrough Therapy Designation.
• Pemziviptadil (PB1046) A long-acting vasoactive intestinal peptide (VIP) analogue originally developed using the ELP technology platform for once-weekly subcutaneous treatment of pulmonary arterial hypertension; Phase 2b development voluntarily terminated in December 2021 due to COVID-19 impacts on manufacturing, drug supply, and enrollment.
• PB6440 An oral, highly selective aldosterone synthase inhibitor in pre-IND development for treatment-resistant hypertension and potentially other cardio-renal indications; designed to address limited treatment options for patients with resistant hypertension and elevated cardiovascular and renal risks.
• Elastin-Like Polypeptide (ELP) Technology Platform Proprietary elastin-like polypeptide (ELP) technology platform for developing biologics and peptides with extended half-life, less-frequent dosing, and improved pharmacokinetics; engineered pemziviptadil and drives both internal and partnership-based drug-development opportunities.

Quantifiable outcome

• Bentracimab achieved 135% reduction in platelet inhibition within 5-10 minutes after initiation (P<0.001)
• +3 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered core.

• Berkshire Sterile ManufacturingcoreOEM/ Whitelabel/ Licensing Partner · 8 March 2022Manufacturing partnership with Berkshire Sterile Manufacturing (Lee, MA) for drug product manufacturing. The completion of drug substance and drug product Process Performance Qualification (PPQ) campaign was announced in March 2022, consisting of multiple commercial scale runs required for validation of bentracimab manufacturing process and demonstration of batch-to-batch consistency at commercial scale.
• Alfasigma S.p.AcoreChannel Partner/ Reseller/ Distributor · 17 June 2021Exclusive licensing agreement with Alfasigma S.p.A., a privately owned specialty pharmaceutical company focused on commercializing medicines in Europe and other key markets. PhaseBio received $20 million upfront payment and is eligible to receive up to $35 million in pre-revenue regulatory milestones and up to $190 million in sales-based payments. PhaseBio will receive tiered royalties starting in low double digits up to mid-twenties on net sales. This collaboration reinforces the global bentracimab opportunity and establishes accessibility to the largest pool of ticagrelor patients in the world.
• BioVectracoreOEM/ Whitelabel/ Licensing Partner · 1 March 2021Commercial scale supply agreement with BioVectra, an innovative global contract development and manufacturing organization (CDMO), for production of bentracimab active pharmaceutical ingredient (API). BioVectra provides integrated CDMO services for manufacturing of bentracimab API for use in Phase 2b and Phase 3 clinical trials and for global commercial supply upon regulatory approval. The partnership includes Windsor, Nova Scotia facility for drug substance manufacturing.
• SFJ PharmaceuticalscoreStrategic or Co-development Partner · 1 January 2020SFJ Pharmaceuticals is a financing and co-development partner for bentracimab in the European Union and China. Under the agreement, SFJ agreed to pay up to $120.0 million to support global development of bentracimab, with $90.0 million initial funding plus $30.0 million upon meeting pre-defined clinical milestones. SFJ has provided $91.3 million through December 2021 and is leading clinical development efforts in China. SFJ is also leading the IND application process in China, where the CDE approved the IND application in August 2021.

Scale indicators10 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Amarin Corporation: Cardiovascular specialty pharmaceutical company focused on Vascepa (icosapent ethyl) for cardiovascular risk reduction. Comparable as a publicly-traded, single-asset-focused cardiovascular specialty pharma with concentrated revenue dependence and physician-driven commercial model.
• Esperion Therapeutics: Cardiovascular specialty pharmaceutical company developing bempedoic acid (Nexletol) for LDL-cholesterol lowering in statin-intolerant patients. Similar profile as a late-stage commercial-stage cardiovascular specialty company navigating payor and physician adoption.
• Portola Pharmaceuticals: Developer of AndexXa (andexanet alfa), a biologic reversal agent for Factor Xa anticoagulants. Closest direct analog to bentracimab in mechanism (antibody fragment reversal), regulatory pathway (Breakthrough Designation, accelerated approval), and critical-care commercial model; acquired by Alexion in 2020.

Peers

• Corcept Therapeutics:

Broad incumbents

• Alexion (AstraZeneca Rare Disease): Acquired Portola Pharmaceuticals and now markets AndexXa (andexanet alfa), the first FDA-approved reversal agent for Factor Xa inhibitors. Directly comparable mechanism (antibody-based anticoagulant reversal) and critical-care commercial model make it the closest analog to bentracimab's intended use case.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key highlights6 records

Customer concentration

• Xx.com/PhaseBio
• LinkedInlinkedin.com/company/phasebio-pharmaceuticals
• Facebookfacebook.com/167230046625699

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds11 records

Investors16 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about PhaseBio Pharmaceuticals