KALA BIO, Inc. - KALA STOCK NEWS

Kala Pharmaceuticals (NASDAQ:KALA) announced that the FDA has granted Fast Track designation for its KPI-012 therapy, aimed at treating persistent corneal epithelial defect (PCED), a rare and serious eye condition affecting approximately 100,000 patients in the U.S. This designation aims to expedite the development and review process, facilitating more frequent interactions with the FDA. KPI-012, based on a human mesenchymal stem cell secretome (MSC-S) platform, seeks to address the unmet medical needs of PCED patients, for whom no approved treatments currently exist. Kala is advancing its Phase 2b clinical trial, with promising initial safety results reported, and aims to present topline data in Q1 2024, potentially using this trial as one of the two pivotal studies required for a Biologics License Application (BLA).

Kala Pharmaceuticals (NASDAQ: KALA) has appointed Dr. Francis Mah as Chief Medical Advisor. Dr. Mah, an expert in corneal disease, will support the company’s clinical development, particularly for KPI-012, its treatment for Persistent Corneal Epithelial Defect (PCED). Recently, Kala reported positive safety data from its CHASE Phase 2b trial of KPI-012. Dr. Mah's extensive experience and research background will aid in advancing KPI-012 and exploring its application for other rare ocular diseases. PCED affects approximately 100,000 people annually in the U.S., underscoring the need for effective therapies.

Kala Pharmaceuticals announced positive safety data from the first cohort of its CHASE Phase 2b trial for KPI-012, aimed at treating persistent corneal epithelial defect (PCED). The initial cohort involved two patients treated with a high-dose regimen, both of whom completed the treatment without safety issues. The trial is now progressing to Cohort 2, which will assess the safety and efficacy of two doses of KPI-012 in about 90 patients. Topline data is expected in Q1 2024, and positive results could pave the way for pivotal trials supporting a Biologics License Application to the FDA.

Kala Pharmaceuticals, Inc. (NASDAQ: KALA), a clinical-stage biopharmaceutical firm focused on innovative therapies for severe eye diseases, will present at the Oppenheimer 33rd Annual Healthcare Conference on March 15, 2023. A virtual fireside chat with management is scheduled for 12:00 p.m. ET, along with one-on-one meetings available on the same day. Kala is advancing its lead product candidate, KPI-012, designed to address persistent corneal epithelial defect and has received orphan drug designation from the FDA. The company aims to explore additional indications, including Partial Limbal Stem Cell Deficiency and retinal degenerative diseases.

Kala Pharmaceuticals (NASDAQ: KALA) has enrolled its first patient in the CHASE Phase 2b clinical trial for KPI-012, targeting top-line data by 1Q 2024. The company closed a $31.0 million private placement financing, extending its cash runway into 1Q 2025. Following the sale of its commercial portfolio to Alcon in July 2022, Kala reported a net loss of $12.8 million for Q4 2022, down from $47.6 million in Q4 2021. R&D expenses increased to $3.3 million, primarily due to costs related to KPI-012 development. As of December 31, 2022, Kala had cash and cash equivalents of $70.5 million.

Kala Pharmaceuticals (NASDAQ:KALA) announced the FDA's acceptance of its IND application for KPI-012, its lead product candidate targeting persistent corneal epithelial defect (PCED). The company is set to initiate a Phase 2b clinical trial in 1Q 2023 with topline data expected in 1Q 2024. Additionally, Kala completed a private placement financing, raising $25 million, bringing total proceeds to $31 million. KPI-012 aims to be the first approved treatment for PCED, a rare eye condition affecting approximately 100,000 individuals annually in the U.S.

Kala Pharmaceuticals announced the submission of an IND application for KPI-012 to the FDA, targeting Persistent Corneal Epithelial Defect (PCED). The company plans to initiate a Phase 2b trial by Q4 2022, with topline data projected for Q1 2024. Upon FDA acceptance, Kala will receive additional financing that extends its cash runway into Q1 2025. KPI-012 addresses a rare eye disease, impacting around 100,000 individuals annually in the U.S., and has the potential to become the first approved treatment for PCED. Mark Iwicki highlighted the significance of this advancement in ocular therapies.

Kala Pharmaceuticals, Inc. (NASDAQ:KALA) has entered into a definitive agreement for a private placement to raise up to $31 million. The first tranche includes the sale of 76,813 shares of common stock at $5.75 per share, and 9,666 shares of Series E Preferred at $575.00 per share, expected to close by December 1, 2022. The second tranche, contingent on FDA acceptance of their IND application for KPI-012 in treating persistent corneal epithelial defect, could yield an additional $25 million. Proceeds will advance the clinical development of KPI-012.