What Kinnear Pharmaceuticals does

Kinnear Pharmaceuticals, LLC is a preclinical-stage biopharmaceutical company operating as a wholly-owned subsidiary of N8 Medical, Inc. (also referred to as N8 Biosciences). The company develops Ceragenin-based anti-infective and anti-inflammatory therapies, with a primary focus on treating serious bacterial and fungal infections in Cystic Fibrosis (CF) patients and other populations with limited therapeutic options. The core technology centers on Ceragenins — synthetic non-peptide small molecules modeled after the host defense peptide LL-37. These compounds feature a sterol backbone adorned with amino acid substituents and carry a positive charge that selectively disrupts negatively charged microbial cell membranes. Unlike natural LL-37, Ceragenins are not susceptible to proteolytic degradation, retain activity in high-salt and high-mucus CF environments, and have shown no resistance development across 30x serial passaging studies. Lead candidate CSA-131 is being developed as an inhaled drug for prevention and treatment of Pseudomonas aeruginosa lung infections in CF patients, with documented efficacy against ESKAPE pathogens, Candida auris, Aspergillus, and Colistin-resistant strains. FDA granted CSA-131 Qualified Infectious Disease Product (QIDP) Designation in July 2023, providing five years of additional market exclusivity upon approval and Fast Track eligibility. Kinnear is pre-revenue, with development funded through non-dilutive sources including a Cystic Fibrosis Therapeutics Foundation grant, three SBIR grants supporting CSA-131-coated medical devices (hemodialysis catheters, pedicle screws, pacemaker envelopes), and a Cystic Fibrosis Foundation investment. The pipeline extends beyond CF into Multiple Myeloma and Dengue indications. Future pharmaceutical commercialization is contemplated via enterprise field sales to CF treatment centers, hospitals, and specialty pharmacies. The CeraShield Endotracheal Tube, an FDA Breakthrough Device (Designation 2018) coating application of CSA-131, is commercialized internationally by parent N8 Medical in Canada, Brazil, and Colombia.

Name

Kinnear Pharmaceuticals

Legal name

Kinnear Pharmaceuticals, LLC

Website

https://kinnearpharma.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

1–10 employees

Short description

Kinnear Pharmaceuticals is a preclinical-stage biopharmaceutical subsidiary of N8 Medical developing Ceragenin-based antimicrobial therapies, with lead candidate CSA-131 in inhaled form for preventing Pseudomonas aeruginosa lung infections in cystic fibrosis patients.

Ownership category

akta.pro rank

Product category

Anti-infective Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Pulmonology & Allergy Specialty Pharmaceuticals (HLAIACAF)

akta.pro secondary industries

Cystic Fibrosis & Bronchiectasis Care (HLAKANAK), Inhalation & Nebulization Devices (Nebulizers, Spacers, Inhaler Accessories) (HLAHAGAE)

Keywords

• Antimicrobial drug development
• Cystic fibrosis therapy
• Ceragenin pharmaceuticals
• Inhaled anti-infectives
• Medical device coatings

Headquarters

HQ city

Las Vegas

HQ country

United States

HQ region

North America

Offices3 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. Pharmaceutical Drug Development (CSA-131): Pre-revenue. Kinnear is a preclinical-stage company developing CSA-131 as an inhaled drug for prevention and treatment of Pseudomonas aeruginosa lung infections in cystic fibrosis patients. FDA QIDP Designation grants five years of additional market exclusivity upon approval. Multiple pipeline indications including Multiple Myeloma and Dengue are in development.
2. Medical Device Platform (CeraShield ETT): CeraShield Endotracheal Tube is approved and commercialized in Canada, Brazil, and Colombia through the parent company N8 Medical. Revenue model for Kinnear may include licensing royalties from parent N8 Medical for the Ceragenin technology platform used in device coatings. The device targets prevention of Ventilator Associated Pneumonia in ICU patients.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Kinnear Pharmaceuticals is a preclinical-stage biopharmaceutical company developing Ceragenin (CSA) based therapeutics, with lead candidate CSA-131 being formulated as an inhaled drug to prevent and treat Pseudomonas aeruginosa and other bacterial/fungal lung infections in Cystic Fibrosis patients. The company also participates in the broader CeraShield medical device coating platform through its parent N8 Medical, with applications such as the CSA-131-coated CeraShield Endotracheal Tube to prevent ventilator-associated pneumonia in ICU patients.

Product overview

Kinnear Pharmaceuticals is a preclinical-stage biotech company developing Ceragenin-based treatments. The company's core offerings include: (1) CSA-131, an inhaled drug compound for preventing and treating Pseudomonas infections in Cystic Fibrosis patients, (2) CeraShield Technology, an antimicrobial coating platform for medical devices to prevent hospital-acquired infections, and (3) CeraShield Endotracheal Tube, a drug-eluting ETT utilizing the coating technology. The company is a subsidiary of N8 Biosciences and leverages the broader Ceragenin platform developed at Brigham Young University.

Differentiator

Problem solved

Functional benefit

Products and services

• CSA-131 (Inhaled Drug Candidate) Synthetic non-peptide ceragenin compound modeled after host defense peptide LL-37, formulated as an inhaled drug to prevent and treat recurrent Pseudomonas aeruginosa lung infections in Cystic Fibrosis patients. Active against ESKAPE pathogens, Candida auris, Aspergillus, and Klebsiella pneumoniae; retains activity in CF mucus environments where conventional antibiotics fail.
• CeraShield Endotracheal Tube (CeraShield ETT) CSA-131 drug-eluting endotracheal tube designed to prevent Ventilator Associated Pneumonia (VAP) in mechanically ventilated ICU patients by inhibiting biofilm fouling on the device surface. FDA Breakthrough Device designated; commercialized internationally by parent company N8 Medical.

Quantifiable outcome

• CSA-131 showed MIC of <0.5 mg/L against Pseudomonas aeruginosa (best activity among four ceragenins tested)
• +5 more outcomes

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Eight partnerships are on record, tiered major, core and minor.

• University of BarcelonamajorStrategic or Co-development Partner · 7 September 2015Professor Jordi Vila and colleagues at the University of Barcelona, Spain conducted a study published in the International Journal of Antimicrobial Agents finding that CSA-131 is highly effective against Colistin-resistant strains of Pseudomonas and Acinetobacter. This independent academic validation demonstrated CSA-131's efficacy against the most resistant bacterial strains.
• N8 Medical, Inc. (Parent Company)coreOthersKinnear Pharmaceuticals, LLC is a subsidiary of N8 Medical, Inc. (also referred to as N8 Biosciences in some contexts). N8 Medical is the parent company focused on commercialization of CeraShield technology for medical devices. Robert D. Mitchell is CEO of N8 Medical, Inc. Kinnear focuses on pharmaceutical drug development while the parent handles medical device commercialization.
• Brigham Young University (BYU)coreStrategic or Co-development PartnerThe Ceragenin technology platform was invented by Professor Paul B. Savage, Reed M. Izatt Professor of Chemistry and Biochemistry at Brigham Young University. CSA-131 was co-authored with BYU. The company's proprietary technology is based on Dr. Savage's research and invention. The technology is exclusively licensed from BYU.
• U.S. Centers for Disease Control and Prevention (CDC)majorStrategic or Co-development PartnerCDC co-authored a peer-reviewed publication in The Journal of Antimicrobial Chemotherapy with N8 Medical on the activity of ceragenin CSA-131 against 100 strains of Candida auris collected from around the world. CDC provided valuable testing services. The collaboration provides independent third-party validation of CSA-131 efficacy data.
• Weill Cornell Medical CentermajorStrategic or Co-development PartnerDr. Michael Niederman, Clinical Director and Associate Chief in the division of Pulmonary and Critical Care Medicine at Weill Cornell Medical Center, and Professor of Clinical Medicine at Weill Cornell Medical College, serves as Chairman of N8 Medical's Scientific Advisory Board and provides strategic guidance on clinical development of CSA-131.
• Kingston General HospitalmajorStrategic or Co-development PartnerThe CEASE-VAP clinical study is underway at Kingston General Hospital in Kingston, Ontario, led by Professor John Muscedere. The study evaluates comparative efficacy of the CeraShield ETT vs. an uncoated ETT with subglottic suctioning feature in preventing VAP. Over 125 patients enrolled with target enrollment of 400 patients.
• Prime Hospital (UAE)minorStrategic or Co-development PartnerA clinical study of the CeraShield ETT is underway at Prime Hospital in the United Arab Emirates, with additional studies planned in Saudi Arabia, Panama, and Colombia. This represents international clinical trial expansion for the medical device platform.
• Hackensack Meridian Health Center for Discovery and InnovationminorStrategic or Co-development PartnerDavid S. Perlin, Ph.D. serves as Scientific Consultant to Kinnear Pharmaceuticals. He is the founding Chief Scientific Officer and Senior Vice President for the Hackensack Meridian Health Center for Discovery and Innovation, providing scientific advisory expertise.

Scale indicators7 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Vertex Pharmaceuticals: Dominant franchise in Cystic Fibrosis through CFTR modulators (Trikafta/Kaftrio). Vertex defines the competitive landscape Kinnear's CSA-131 would enter, and its success in reducing pulmonary exacerbations directly shapes the future addressable patient population.

Direct peers

• Insmed Incorporated: Develops inhaled anti-infectives for chronic lung diseases (e.g., Arikayce for MAC lung infections). Closely comparable to Kinnear's inhaled anti-infective approach for CF pulmonary infections, with similar regulatory pathways and commercialization challenges.
• Savara Inc. Focused on inhaled therapies for rare respiratory diseases including CF. Develops molgramostim nebulizer solution targeting chronic infections in CF, sharing Kinnear's inhaled-delivery CF anti-infective positioning.

Emerging players

• AN2 Therapeutics: Clinical-stage biopharma developing epetraborole for chronic Mycobacterium avium complex (MAC) lung disease. Comparable as a small anti-infective developer targeting resistant lung pathogens via novel mechanisms.
• Iterum Therapeutics: Develops oral antibiotics against multi-drug resistant pathogens, including those on the WHO priority list. Comparable as a small-cap anti-infective developer focused on resistance.
• Cidara Therapeutics: Develops novel anti-infectives including Cloudbreak antiviral and antibacterial drug-Fc conjugates. Comparable as a clinical-stage anti-infective platform addressing resistant pathogens.
• Paratek Pharmaceuticals: Develops tetracycline-class antibiotics (Nuzyra/omadacycline) for serious community-acquired infections. Comparable as a specialty anti-infective company focused on resistant pathogens.
• VenatoRx Pharmaceuticals: Clinical-stage anti-infective developer targeting MDR Gram-negative infections with novel beta-lactamase inhibitors. Comparable in size and stage as a developer of new mechanisms against resistant pathogens.
• Pulmatrix Inc. Develops inhaled dry-powder therapeutics for respiratory diseases. Comparable in targeting pulmonary drug delivery via innovative formulations, though focused on different indications (asthma, COPD).
• Nabriva Therapeutics: Develops lefamulin (Xenleta), a pleuromutilin antibiotic approved for community-acquired bacterial pneumonia. Comparable as a small-cap anti-infective company navigating commercialization of novel antibiotics.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/n8-medical-inc-

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds1 record

Investors1 record

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 Kinnear Pharmaceuticals