Kala Pharmaceuticals Announces FDA Acceptance of IND Application for KPI-012 for the Treatment of PCED

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Kala Pharmaceuticals, Inc.

Kala Pharmaceuticals, Inc.

— On track to begin Phase 2b testing in Q1 2023; Key data expected in Q1 2024 —
— Received remaining investment of $25 million under previously announced private placement financing —

ARLINGTON, Mass., Dec. 27, 2022 (GLOBE NEWSWIRE) — Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted an investigational new drug application ( IND) for the company’s lead product candidate, KPI-012, a human mesenchymal stem cell secretome (MSC-S), initially in development for the treatment of persistent corneal epithelial defect (PCED).

“The acceptance of the KPI-012 IND is an important milestone for Kala as we work to translate the promise of our MSC-S platform into better outcomes for people living with rare ocular surface diseases,” said Kim Brazzell, Ph.D. . , head of R&D and chief medical officer at Kala Pharmaceuticals. “We are now turning our focus to clinical execution. We are working closely with investigators to begin our Phase 2b clinical trial of KPI-012 for PCED in the first quarter of 2023.”

The Phase 2b clinical trial will be a multicenter, randomized, double-blind, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of two doses of KPI-012 ophthalmic solution compared to vehicle when administered topically four times per day (QID) for 56 days. The study is expected to include approximately 90 adult patients with PCED, and the primary endpoint of the study will be complete cure of PCED as measured by fluorescein staining of the cornea. Kala expects to begin trial enrollment in Q1 2023 and report key data in Q1 2024. If results are positive, Kala believes this trial could serve as the first of two critical tests needed to support the submission of a Biological License Application (BLA) to the FDA.

In addition, following FDA acceptance of the IND application for KPI-012 and pursuant to the terms of the private placement announced on November 28, 2022, Kala today sold a total of 43,478 Series E Non-Redeemable Convertible Preferred Shares to a price of $575.00 per share for an investor focused on life sciences, with gross income of $25.0 million. In total, Kala raised aggregate gross proceeds of $31.0 million from the private placement.

About KPI-012 for Persistent Corneal Epithelial Defect (PCED)
Persistent corneal epithelial defect, defined as a persistent corneal defect or wound that does not heal and is refractory to conventional treatments, is a rare disease with an estimated incidence of 100,000 cases per year in the United States. PCED can have a variety of etiologies including neurotrophic keratitis, surgical epithelial debridement, microbial/viral keratitis, corneal transplantation, limbal stem cell deficiency, and mechanical and chemical trauma and, if left untreated, can lead to corneal infection, ulceration, or perforation , scarring, opacification and significant loss of vision.

Based on its multifactorial mechanism of action and the preclinical and clinical data generated to date, Kala believes that KPI-012 could represent a significant advance in the treatment of PCED and may become the first approved treatment for PCED in all its various etiologies.

About Kala Pharmaceuticals, Inc.
Kala is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare eye diseases. Kala’s investigational biologics-based therapies utilize Kala’s proprietary Mesenchymal Stem Cell Secretome (MSC-S) platform. Kala’s lead product candidate, KPI-012, is a human MSC-S, which contains several human-derived biofactors such as growth factors, protease inhibitors, matrix proteins, and neurotrophic factors that can potentially correct impaired corneal healing which is an underlying etiology of multiple serious eye diseases. KPI-012 is currently in clinical development for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing, for which it has received orphan drug designation from the US Food and Drug Administration. Kala is also targeting the potential development of KPI-012 for the treatment of Partial Limbal Stem Cell Deficiency and moderate to severe Sj√∂gren’s ocular manifestations and plans to initiate preclinical studies to evaluate the potential usefulness of its MSC- S for retinal degenerative diseases. For more information about Kala, visit www.kalarx.com.

Forward-looking statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. Any statements in this press release regarding Kala’s expectations, plans and future prospects, including, without limitation, statements regarding Kala’s expectations regarding the potential benefits of KPI-012 and its MSC-S platform; anticipated timelines for starting the KPI-012 Phase 2b clinical trial and reporting key data; Phase 2b clinical trial design; the clinical usefulness of KPI-012 for PCED; plans to continue research and development on KPI-012 and its MSC-S platform for further indications and other statements containing the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “forecast”, “project”, “target”, “potential”, “likely”, “will”, “would”, “could”, “should”, “continue” and similar expressions constitute forecasts future statements. Actual results could differ materially from those indicated by such forward-looking statements as a result of several important factors, including: Kala’s ability to perform under the terms of its outstanding loan agreement; uncertainties inherent in initiating and conducting preclinical studies and clinical trials; uncertainties about the availability and timing of clinical trial data; whether the results of initial clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials; whether the KPI-012 Phase 1b clinical trial results will be indicative of results for any future KPI-012 clinical trials and studies, including the planned Phase 2b clinical trial; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; Kala’s ability to retain and hire key personnel; the impact of extraordinary external events, such as the current pandemic health event stemming from the novel coronavirus (COVID-19), and its collateral consequences; the sufficiency of cash resources and the need for additional financing and other important factors, any of which could cause Kala’s actual results to differ from those contained in the forward-looking statements discussed in the “Risk Factors” section of Kala’s Annual Report Kala on Form 10-K, most recently filed quarterly report on Form 10-Q, and other filings Kala makes with the Securities and Exchange Commission. These forward-looking statements represent the views of Kala as of the date of this press release and should not be relied upon as representing the views of Kala as of any date subsequent to the date hereof. Kala undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact:
Hannah Deresiewicz


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