Kala Pharmaceuticals

KALA

Waltham, United States· Est. 2009

kalarx.com

Is this your company? Claim your profile to update info and connect with investors.

Claim profile

KALA · Stock Price

USD 0.08-3.34 (-97.57%)

Market Cap: $62.8M

Historical price data

Market Cap: $62.8MPipeline: 11 drugs (6 Phase 3)Founded: 2009Employees: 11-50HQ: Waltham, United States

Sector Ranking#98 in Drug Delivery & Formulation #73 in Rare & Orphan Diseases

Overview

Kala Bio is a clinical-stage biotech focused on developing regenerative therapies for rare ocular surface and retinal diseases using its proprietary mesenchymal stem cell secretome (MSC-S) platform. The company executed a strategic transformation in 2022, divesting its two FDA-approved commercial products to Alcon to concentrate resources on its novel biologic pipeline. Its lead asset, KPI-012, is in Phase 2b development for persistent corneal epithelial defect (PCED), with potential in other severe surface disorders. Kala's mission is to leverage advanced science to solve serious eye diseases and change patients' lives.

OphthalmologyRare Diseases

Technology Platform

Proprietary mesenchymal stem cell secretome (MSC-S) platform for developing regenerative therapies, complemented by legacy expertise in mucus-penetrating particle (MPP) drug delivery technology.

Pipeline

11 drugs in pipeline6 in Phase 3

Drug	Indication	Stage
loteprednol etabonate 0.25% ophthalmic suspension	Corneal Endothelial Dystrophy	Approved
KPI-121 1% Ophthalmic Suspension dosed BID + Vehicle of KPI-...	Post Surgical Ocular Inflammation and Pain	Phase 3
KPI-121 1% + Prednisolone acetate	Ocular Inflammation	Phase 3
KPI-121 Ophthalmic Suspension + Vehicle	Kerato Conjunctivitis Sicca	Phase 3
KPI-121 0.25% Ophthalmic Suspension + Vehicle of KPI-121 0.2...	Dry Eye Syndromes	Phase 3

Funding History

Total raised:$180M

IPO$70MUndisclosedJul 20, 2017

Series C$50MPolaris PartnersJun 15, 2014

Series B$35MPolaris PartnersJun 15, 2012

Series A$25MPolaris PartnersJun 15, 2010

Opportunities

Kala Bio has a first-mover opportunity to develop the first FDA-approved pharmacologic therapy for Persistent Corneal Epithelial Defect (PCED), a severe orphan condition with no current treatments.

Success could also validate its novel MSC-S platform, unlocking potential in other rare ocular surface diseases like Limbal Stem Cell Deficiency and, longer-term, in inherited retinal disorders.

Risk Factors

The company faces extreme binary risk, with its entire valuation dependent on the success of its lead asset, KPI-012, in an ongoing Phase 2b trial.

Financial liquidity is a pressing concern, with cash runway only into Q2 2025, necessitating a capital raise that could be highly dilutive, especially if clinical data are negative.

Competitive Landscape

In its new focus area of rare ocular diseases, Kala faces limited direct drug competition, primarily competing against off-label therapies and surgical interventions. However, the long-term retinal disease space for KPI-014 is highly competitive with advanced gene and neuroprotective therapies. The company's primary advantage is its first-mover potential and orphan drug status in niche indications.