KALA KALA BIO Inc

KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced the resignation of Chief Executive Officer (CEO) Mark Iwicki, and the appointment of Todd Bazemore, KALA’s President and Chief Operating Officer, as interim CEO, effective immediately. Mr. Iwicki will continue to serve as Chair of the Board of Directors of KALA following the transition. Mr. Bazemore has served as KALA’s President since December 2021 and as KALA’s Chief Operating Officer since November 2017.

Mr. Iwicki stated, “I am proud of the work we have done at KALA utilizing our MSC-S platform, and I am very excited about the potential of our lead product candidate, KPI-012 for the treatment of PCED. As we approach our topline data from the ongoing Phase 2b clinical trial of KPI-012 in the second quarter of 2025, it is the right time to transition leadership to Todd, who I have had the privilege of working closely with for the past seven years. I look forward to continuing to partner with him as Chair of the Board and supporting our mission of delivering innovative therapies for rare and severe diseases of the eye.”

“It is a privilege to continue to build on the strong foundation that Mark and the rest of our team established at KALA. As a leader in the emerging field of mesenchymal stem cell secretomes, we are committed to developing and delivering therapies with the ultimate goal of preserving vision and changing lives,” said Mr. Bazemore, interim CEO of KALA. “I look forward to working closely with the cross-functional team towards the completion of the CHASE trial of KPI-012 in PCED and advancing this important program for patients and physicians.”

Mr. Bazemore brings over 30 years of experience spanning from ultra-rare orphan diseases to large primary care conditions. He has served as KALA’s President since December 2021 and as KALA’s Chief Operating Officer since November 2017. Prior to joining the company, Todd served as Executive Vice President and Chief Operating Officer of Santhera Pharmaceuticals (USA), Inc. responsible for U.S. operations from September 2016 to November 2017. Before that, between April 2014 and January 2016, Todd served as Executive Vice President and Chief Commercial Officer of Dyax Corp. where he was responsible for global commercial strategy and oversight of all commercial functions up until Dyax was acquired by Shire plc. Prior to joining Dyax, Todd was at Sunovion Pharmaceuticals, Inc. where he served in several roles of increasing responsibility including Vice President, Managed Markets, Vice President of Sales, and Vice President of the Respiratory Business Unit. 

About KALA BIO, Inc.

KALA is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye. KALA’s biologics-based investigational 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 numerous human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular 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 and Fast Track designations from the U.S. Food and Drug Administration. KALA is also targeting the potential development of KPI-012 for the treatment of Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision and has initiated preclinical studies to evaluate the potential utility of its MSC-S platform for retinal degenerative diseases, such as Retinitis Pigmentosa and Stargardt Disease.

Cautionary Note Regarding 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 about KALA’s future expectations, plans and prospects, including but not limited to statements about KALA’s expectations with respect to potential advantages of KPI-012 and its MSC-S platform; the clinical utility of KPI-012 for PCED; anticipated timelines to report topline data for the CHASE Phase 2b clinical trial of KPI-012; KALA’s chief executive officer transition; and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: market conditions; uncertainties regarding availability and timing of data from clinical trials; whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials; whether results of the Phase 1b clinical trial of KPI-012 will be indicative of results for any future clinical trials and studies of KPI-012, including the CHASE trial; whether interim data from a clinical trial will be predictive of the results of the trial; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; and other factors discussed in the “Risk Factors” section of KALA’s Annual Report 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 KALA’s views as of the date of this press release and should not be relied upon as representing KALA’s views as of any date subsequent to the date hereof. KALA does not assume any 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:

Taylor Steinertaylor.steiner@precisionaq.com212-362-1200