ARLINGTON, Mass., Sept. 02, 2025 (GLOBE NEWSWIRE) -- 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 that Todd Bazemore has been named President and Chief Executive Officer (CEO) of KALA BIO and appointed to the Board of Directors. Mr. Bazemore has served as KALA's interim CEO since February 2025 and previously served as KALA's President and Chief Operating Officer (COO).

"Throughout his tenure, including as interim CEO and President and COO, Todd's leadership has been instrumental in driving KALA's clinical progress and strategy," said Mark Iwicki, Chair of the Board of Directors of KALA BIO. "In addition to Todd's deep understanding of KALA, he brings over a decade of experience in rare disease, along with a proven track record of global commercial leadership spanning sales, marketing and market access. We believe this uniquely positions him to steer KALA through this pivotal period, as the Company approaches a key data readout that could enable the transition toward commercialization and realize the promise of our mesenchymal stem cell secretome (MSC-S) platform."

"I am excited to continue leading KALA during this important inflection point for the Company, as we approach the upcoming readout of our Phase 2b CHASE trial of KPI-012 in persistent corneal epithelial defect (PCED). We are entering a defining period in the evolution of KALA, as we prepare for the potential transition from a clinical-stage biotechnology company towards our goal of becoming a fully integrated organization with commercial capabilities," said Todd Bazemore, President and Chief Executive Officer of KALA BIO. "We believe KPI-012's multifactorial mechanism of action has the potential to address all underlying etiologies of PCED, an orphan condition with high unmet medical need for which there are no FDA-approved products that address all underlying etiologies. In addition, we believe our MSC-S platform represents a potential transformative approach to treating rare and severe ocular diseases beyond PCED for multiple conditions in both the anterior and posterior segments of the eye."

Mr. Bazemore brings over 30 years of experience across ultra-rare orphan diseases to large primary care conditions. He has served as KALA BIO's interim Chief Executive Officer since February 2025 and previously served as its Chief Operating Officer from November 2017 to February 2025. 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, Mr. Bazemore 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, he was at Sunovion Pharmaceuticals, Inc., previously Sepracor Inc. prior to its acquisition by Dainippon Sumitomo Pharma where he launched 7 new products in an 11-year span while serving 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 belief that the CHASE Phase 2b trial could serve as a pivotal trial to support the submission of a BLA to the FDA; KALA's plans to pursue research and development of KPI-012, KPI-014, and its MSC-S platform for other indications; the sufficiency of KALA's existing cash resources for the period anticipated; and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "likely," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would," 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: uncertainties inherent in the initiation and conduct of preclinical studies and clinical trials; 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 Phase 2b clinical 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; KALA's ability to retain and hire key personnel; KALA's ability to comply with the covenants under its loan agreement, including the requirement that its common stock continue to be listed on The Nasdaq Stock Market; the sufficiency of cash resources and 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 on Form 10-K, most recent 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 Steiner

taylor.steiner@precisionaq.com

212-362-1200

KALA BIO Appoints Todd Bazemore as President, Chief Executive Officer and Director