TORONTO, April 01, 2026 (GLOBE NEWSWIRE) -- Kala Bio Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company at the forefront of artificial intelligence and cell and gene therapy innovation, today announced the engagement of Dr. Saeid Babaei, PhD, MBA, as Senior Scientific Advisor.

Dr. Babaei's engagement will focus on advising on the evaluation of Kala's clinical and molecular assets, including the proprietary MSC Secretome platform, through the potential application of AI-enabled analytics, digital health tools, and secure data integration approaches. His mandate includes advising on clinical development considerations, assessing hypotheses related to potential responder subgroups, and contributing scientific input to the development of a responsible, regulatory-conscious analytical framework for enterprise-scale biotech applications.

Strategic Context: Unlocking Value Through Amended Indications

This collaboration marks a pivotal step in Kala Bio's strategy to maximize the commercial and scientific value of its existing clinical assets through innovation and precision analytics. The initial phase will include a review of historical datasets, trial protocols, and translational hypotheses to help inform strategic considerations for future development and potential partnering, licensing, or commercialization pathways.

"We will be undertaking a rigorous review of our data to evaluate whether amended indications or revised development strategies may merit further consideration. There are many examples in biopharma where a refined indication strategy has created significant value, and we believe our Phase 2 dataset warrants a disciplined reassessment," said Avi Minkowitz, Chief Executive Officer of Kala Bio.

AI-Enabled Research and Market Opportunity

Clinical trials generate vast volumes of data, biological samples, biomarkers, outcomes, and operational metadata that often remain underutilized after primary endpoints are reported. Kala Bio's structured re-analysis, supported by AI and machine learning tools, is intended to explore whether clinically relevant patterns or potential responder hypotheses may be identified to inform future therapeutic development decisions.

A central focus of this engagement is evaluating Kala's work in the MSC secretome space. The secretome, the collection of bioactive molecules and extracellular vesicles secreted by mesenchymal stem cells, represents one of the most rapidly advancing frontiers in regenerative biologics and cell and gene therapies. Industry analysts project the mesenchymal stem cell market to grow from approximately USD 5.1 billion in 2026 to USD 9.1 billion by 2031, reflecting a compound annual growth rate exceeding 12%. Secretome-derived therapies and extracellular vesicle platforms represent a significant component of that expansion.

Dr. Babaei's assessment will help evaluate the scientific and potential commercial relevance of Kala's secretome platform and consider possible pathways for future development, partnering, licensing, or strategic collaboration.

"We are pleased to engage Dr. Babaei as a top scientific partner in this critical phase of Kala's evolution," said Avi Minkowitz, Chief Executive Officer of Kala Bio. "His experience contributing to clinical research and development programs across oncology, genomics, and biologics brings a valuable scientific and strategic perspective at this stage. Our focus is to rigorously analyze these assets and determine whether there may be a structured path forward, including possible development, partnering, commercialization, or licensing opportunities."

"KALA Bio has assembled a meaningful scientific dataset that warrants a careful and structured reassessment," commented Dr. Babaei. "My focus is to evaluate where the underlying evidence may support new insight, help shape a more informed future development strategy, and enable the responsible application of AI-enabled analysis, including an objective assessment of the scientific merits and potential strategic relevance of KALA's secretome platform."

About Dr. Saeid Babaei

Dr. Saeid Babaei, PhD, MBA, is a serial biotech entrepreneur and executive leader with over 28 years of experience founding, financing, and scaling healthcare and life science companies across genomics, diagnostics, and oncology. He has overseen more than 25 strategic transactions, raised over $50 million, and contributed to multiple clinical research and development programs spanning oncology, genomics, and biologics. Dr. Babaei currently serves as Chairman and CEO of Virotek Biosciences and Managing Director of Ameretat Investment. He is also a Professor of Entrepreneurship and Innovation at the Schulich School of Business, York University.

For Dr. Babaei's full professional profile, visit: linkedin.com/in/saeid-babaei-aa7a19

About Researgency.ai

Researgency.ai is an agentic, on-premises AI platform developed by Kala Bio in collaboration with Younet. Designed for secure, scalable deployment in regulatory-compliant biopharmaceutical environments, Researgency.ai enables biotech companies to turn clinical and molecular data into actionable insights for therapeutic optimization, digital health integration, and commercialization.

ABOUT KALA BIO (NASDAQ:KALA)

KALA BIO, Inc. is a clinical-stage biopharmaceutical company building a dedicated, on-premises AI infrastructure platform for the biotechnology industry. The Company's dual strategy combines a proprietary biologics pipeline—including its mesenchymal stem cell secretome (MSC-S) platform and FDA Orphan Drug- and Fast Track-designated product candidates—with a scalable AI platform-as-a-service business designed to deploy secure, purpose-built AI solutions directly within biotech and pharmaceutical client environments.

Through its exclusive worldwide license for the Researgency AI research platform from Younet, Kala intends to serve as the dedicated AI infrastructure partner for the biotechnology industry, enabling organizations of all sizes to unlock the value of their proprietary biological data without surrendering control. Kala is advancing an agentic transformation strategy for biomedical organizations through Researgency.ai, a platform designed to enable scalable, governed deployment of AI agents across research, documentation, and operational workflows. The Company's focus on enterprise security, real-time performance, and seamless integration positions it at the forefront of innovation in the life sciences AI sector.

Kala believes the future of biomedical innovation is in agentic systems.

For more information, visit www.kalarx.com and www.Researgency.ai

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's strategic initiative to build an AI infrastructure platform for the biotechnology industry, plans to develop and deploy the Researgency AI platform both internally and to external clients, expectations regarding the potential benefits of AI-driven analytical tools, plans to reassess historical datasets and identify new therapeutic indications, expectations regarding the AI drug discovery market and industry trends, expectations regarding the Company's ability to generate recurring platform revenue, plans regarding potential partnerships, client deployments, or technology licensing opportunities, expectations regarding the Company's competitive position and the differentiation of its on-premises deployment model, the potential exercise of development continuation or renewal options under the Agreement, and other statements that are not historical facts.

The Company used words like "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions to identify these forward-looking statements. These statements involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance, or achievements to be materially different from those expressed or implied by such statements. Important factors that could cause such differences include, but are not limited to: risks that AI technologies may not produce expected results in drug discovery or development; risks related to the development, deployment, and performance of the Researgency platform; risks that the Company may not successfully attract or retain external platform clients; risks that the platform-as-a-service business model may not generate anticipated revenues; risks that the Company's product candidates may not be successfully developed or commercialized; risks related to the Company's limited cash resources and ability to continue as a going concern; risks that the third-party information contained herein was not accurate at the time it was published and/or does not accurately predict the future; risks related to the Company's ability to raise future capital and the possibility that market conditions may limit the Company's ability to raise capital on favorable terms; risks related to the Company's ability to regain compliance with Nasdaq listing requirements; competition from larger, better-resourced companies including major technology and pharmaceutical companies; dependence on key personnel and third-party technology providers; the accuracy of third-party market forecasts and projections cited herein; risks that the Company may elect not to expand or continue its deployment of the Researgency platform beyond the initial term; risks that Younet may not perform its obligations under the Agreement; and other risks detailed in the "Risk Factors" section of the Company's Annual Report on Form 10-K as they may be revised in the Company's Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and other filings with the Securities and Exchange Commission.

Forward-looking statements speak only as of the date of this release, and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:

Avi Minkowitz

Chief Executive Officer, KALA BIO, Inc.

am@kalarx.com

www.kalarx.com | www.Researgency.ai

Kala Bio Engages Dr. Saeid Babaei as Senior Scientific Advisor to Evaluate Clinical Assets and Precision Development Opportunities