Kala Pharmaceuticals (KALA) Investor Presentation - Slideshow

Company Strategy and Financial Position - Kala refocused its corporate strategy to advance an innovative pipeline based on its Mesenchymal Stem Cell Secretome (MSC-S) platform[18] - Kala closed a deal with Alcon, divesting commercial products EYSUVIS® and INVELTYS® for initial proceeds of $65 million ($60 million upfront + $5 million inventory) and potential sales milestones of up to $325 million[18] - Kala announced a private placement of up to $31 million, which was fully received in December 2022[18] - As of December 31, 2022, Kala had cash, cash equivalents, and investments of $70.5 million[18] KPI-012 Program for PCED - KPI-012 is Kala's lead MSC-S product, targeting rare ocular surface diseases, including Persistent Corneal Epithelial Defect (PCED), a potential $1 billion+ market opportunity in the US alone[18] - KPI-012 PCED IND was filed and accepted in Q4 2022[18] - The CHASE Phase 2b trial in PCED was initiated in Q1 2023, with top-line data expected in Q1 2024; positive results could serve as the first of two pivotal trials for BLA submission[18] - In a Phase 1b clinical trial, 6 out of 8 (75%) PCED patients experienced complete healing after 1-4 weeks of BID treatment with KPI-012[80] Pipeline and Market Opportunity - Kala is evaluating clinical development of KPI-012 for limbal stem cell deficiency (LSCD) and Sjögren's[18] - Kala has a pre-clinical MSC-S program, KPI-014, for rare inherited retinal diseases[18] - The estimated PCED incidence is approximately 100,000 patients in the US and 238,000 in the US, EU, and Japan combined[40]