KALA BIO, Inc. develops a dual strategy that combines a clinical-stage biologics pipeline for rare and severe eye diseases with an on-premises artificial intelligence infrastructure platform for biotechnology and pharmaceutical clients. Company updates cover the MSC-S platform, the KPI-012 clinical program, Researgency.ai, and the Bionic Intelligence Research Agent for secure research, clinical, regulatory, and data-workflow applications.
News also addresses capital-structure actions and corporate-status developments, including registered equity offerings, debt settlement, Nasdaq listing matters, governance changes, and the completed 1-for-50 reverse stock split of KALA common stock.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) announced its participation at the Jefferies Healthcare Conference in New York, scheduled for June 9, 2022. The management team will hold a fireside chat at 10:30 a.m. ET and will be available for one-on-one meetings on June 8 and 9. The company focuses on innovative eye disease therapies, utilizing its AMPPLIFY® drug delivery technology. Notably, on May 23, 2022, Kala agreed to sell its commercial portfolio to Alcon Inc., with the transaction expected to close in Q3 2022, pending regulatory conditions.
Kala Pharmaceuticals (NASDAQ: KALA) has signed a deal to sell its commercial portfolio, including EYSUVIS and INVELTYS, to Alcon Inc. for $60 million upfront, with additional sales-based milestone payments. This strategic move is aimed at focusing resources on the development of KPI-012, a therapy targeting rare ocular diseases. With this transition, Kala expects a significant reduction in operating expenses, extending its cash runway into Q2 2024. The sale is projected to close in Q3 2022, pending regulatory approvals.
Kala Pharmaceuticals reported Q1 2022 financial results and corporate updates on May 16, 2022. The company achieved 18% growth in EYSUVIS prescriptions and expanded coverage for EYSUVIS to 92% of commercial lives and 30% of Medicare lives. Net product revenues were $1.4 million, a decline from $3.3 million in Q1 2021. Operating loss increased to $30.9 million, with a net loss of $32.9 million, or $0.45 per share. Notably, the company plans to initiate a Phase 2/3 clinical trial for KPI-012 by Q4 2022.
Kala Pharmaceuticals (NASDAQ:KALA) announced it will report its first quarter 2022 financial results on May 16, 2022. A conference call and live audio webcast will follow at 8:00 a.m. ET for discussion of the results and a business update. The public can access the live webcast via the Kala website. The company focuses on innovative eye disease therapies, utilizing its AMPPLIFY® drug delivery technology for products like EYSUVIS® and INVELTYS®. Kala is also advancing its pipeline, including KPI-012 for persistent corneal epithelial defects and new chemical entity programs.
Kala Pharmaceuticals, Inc. (NASDAQ: KALA) announced two major coverage expansions for its product, EYSUVIS. Effective May 1, 2022, the largest Pharmacy Benefit Manager in the U.S. added EYSUVIS to its commercial formularies, increasing total commercial coverage to 155.3 million lives (92% of commercial lives). Additionally, Humana will include EYSUVIS as a Preferred Brand on its Medicare formularies starting June 1, 2022, doubling Medicare coverage to 14.1 million lives (30% of total Medicare lives). These developments aim to enhance prescription fulfillment rates and drive growth.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) announced promising results from its Phase 1b trial of KPI-012, a novel therapy for persistent corneal epithelial defects (PCED). In the study, six out of eight patients (75%) achieved complete healing within four weeks, with all reporting zero pain by week three. KPI-012 was well tolerated, with no significant safety issues. The company plans to file an IND application with the FDA and initiate a Phase 2/3 trial in Q4 2022. This therapy has the potential to address various rare ocular diseases, showcasing its significant therapeutic promise.
Kala Pharmaceuticals (NASDAQ: KALA) announced its presentation of data from a Phase 1b clinical trial of KPI-012 at the 2022 ARVO Annual Meeting in Denver, happening from May 1-4, 2022. The data underscores the potential of KPI-012, a new secretome therapy aimed at treating persistent corneal epithelial defects (PCED). The session will be led by Dr. Valeria Sáanchez-Huerta on May 3, 2022. This presentation supports Kala's ongoing development efforts for innovative ocular therapies, following the successful application of their AMPPLIFY® technology in existing products.
Kala Pharmaceuticals reported $11.2 million in net product revenues for 2021, with $6.3 million from EYSUVIS and $4.9 million from INVELTYS. EYSUVIS prescriptions increased by 21% in Q4 2021. Coverage expanded to 118 million commercial lives and 7.1 million Medicare lives. The company anticipates initiating Phase 2/3 trials for KPI-012 in Q4 2022, following positive clinical results. Despite a significant operating loss of $130.2 million, Kala expects its cash will fund operations through mid-2023.
Kala Pharmaceuticals (NASDAQ:KALA) will announce its fourth quarter and full year 2021 financial results on March 29, 2022. Management will host a conference call at 8:00 a.m. ET to discuss these results and provide a business update. The call can be accessed via domestic and international dial-in numbers or through a live webcast on the company’s website.
Kala focuses on innovative therapies for eye diseases, with products like EYSUVIS® and INVELTYS® using its proprietary AMPPLIFY® drug delivery technology, alongside a pipeline for unmet medical needs.
Kala Pharmaceuticals (NASDAQ:KALA) announced the addition of EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% to UnitedHealthcare's commercial formularies, expanding its coverage to approximately 118 million lives, or 70% of all commercial lives. Cigna Medicare also added EYSUVIS as a preferred brand, increasing its total Medicare coverage to 7.1 million lives, or 15%. EYSUVIS, approved by the FDA in October 2020, is the first FDA-approved treatment for short-term dry eye disease symptoms.