ARLINGTON, Mass., March 30, 2026 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA) ("Kala" or the "Company") today announced the initial commercial deployment of the Bionic Intelligence Research Agent (BIRA), the Company's first purpose-built agentic AI solution delivered through its Researgency.ai platform (under exclusive worldwide license with Younet). This milestone marks Kala's transformation into an operational AI infrastructure partner for the global biotechnology industry.

The launch follows the Company's March 11 announcement that its first AI agent would ship within 14 days, a commitment Kala has met on schedule, demonstrating the Company's ability to execute on commitments and its readiness to deliver commercial-grade AI solutions at enterprise scale.

INDUSTRY-LEADING AI INFRASTRUCTURE FOR BIOTECH

The Bionic Intelligence Research Agent is a fully autonomous AI research specialist built for the biotechnology and pharmaceutical sectors. Powered by Researgent 2.0, a 70-billion-parameter large language model trained on vast datasets in the biotech, healthcare, and scientific research sectors, BIRA delivers next-generation performance within secure enterprise infrastructure.

"Two weeks ago, we told the market that the first agent ships in 14 days. Today, it's live and with the potential to generate huge value," said Avi Minkowitz, CEO of Kala. "The Bionic Intelligence Research Agent is not a demo; it is a working, enterprise-grade product inside private infrastructure right now. Our focus on secure, scalable AI deployment positions Kala at the forefront of the agentic transformation reshaping biomedical research. The pace of AI advancement is evident. Our goal is to maintain timely progress as we work with Younet to build out the Researgency platform for market use, and we intend to keep setting and meeting targets as we advance toward full platform commercialization."

SECURE, PRIVATE AI DEPLOYMENT

Unlike public AI platforms, BIRA operates solely within client-controlled, VPN-secured environments, guaranteeing full data sovereignty with no external access to proprietary research data; enterprise-grade security that complies with pharmaceutical R&D standards; complete audit trails for regulatory documentation; and real-time performance with minimal cloud latency.

CORE PLATFORM CAPABILITIES

Autonomous Research Execution: The platform delivers multi-step query decomposition and cross-source synthesis from scientific literature, clinical trial databases, patent repositories, and pharma intelligence feeds via advanced automation.

Comprehensive Database Connectivity: Pre-built connectors provide integration with scientific literature, clinical and regulatory databases, global IP resources, market intelligence, and business data through a single secure interface.

Private Infrastructure Deployment: VPN-only access ensures all queries, results, and derived intelligence remain within organizational boundaries, maintaining complete security throughout the research workflow.

Quality Assurance & Confidence Scoring: Automated source verification, reliability scoring of quantitative evidence, and explicit flagging of knowledge gaps ensure enterprise-grade performance for research teams.

Research-Ready Visualization: Interactive, customisable graphical presentations designed for R&D decision-making enable real-time analysis and reporting.

SCALABLE AI PLATFORM ARCHITECTURE

BIRA's architecture integrates smoothly with Younet's Researgency platform infrastructure, designed to scale with the complexity of client organisations, leverage existing enterprise infrastructure investments, support a platform-as-a-service model for recurring revenue, and enable swift deployment across multiple business units. This scalable approach ensures that organisations of any size can benefit from the platform's AI solutions without sacrificing security or performance.

NEAR-TERM PRODUCT ROADMAP: FOUR INNOVATIONS IN ACTIVE DEVELOPMENT

Building on BIRA's foundation, Younet's engineering team in collaboration with Kala is actively developing four additional capabilities for near-term release, each representing significant innovation in agentic AI for the life sciences sector:

Daily Compressed Publications Review

An automated, scheduling-driven research digest that delivers AI-compressed summaries of publications across user-defined therapeutic verticals, such as oncology, neurology, and immunology. This automation solution includes text-to-speech for hands-free consumption and uses machine-learning-based priority filtering to highlight the most impactful findings in real time.

Trigger-Defined Real-Time Alerts

A versatile event-monitoring system that supports keyword triggers, alerts for starting clinical trials, notifications for regulatory decisions, and complex logic conditions from multiple sources. Alerts are sent via email, dashboard, mobile, or voice, with ML-driven false-positive reduction to ensure enterprise-grade reliability and performance.

Real-Time IP Filings Monitoring

Continuous monitoring of global patent filings with competitor tracking, technology area analysis, citation review, white-space detection, and freedom-to-operate risk alerts. This platform capability provides biotech and pharma organizations a real-time advantage in IP strategy through seamless integration with existing research workflows.

Prospective Dormant IP Identification

An intelligence module that systematically detects lapsed or abandoned patents with revival potential, cross-checks with client internal research priorities, and produces prioritized strategic recommendations with risk-benefit analysis. This innovation unlocks hidden value in the global IP landscape while maintaining complete security of proprietary analysis.

"There have been breakthrough advances in KV caching, Google's TurboQuant, and MIT's ‘Attention Matching', leading to substantially lower inference costs. This creates new efficiencies in large-scale AI deployment and explains the rapid adoption of agent orchestration frameworks such as OpenClaw and Claude Channels over the past few weeks. We are observing a paradigm shift in how enterprises will deploy autonomous AI systems. The convergence of these technical breakthroughs with our Researgency.ai platform confirms our strategic thesis: that agentic AI will fundamentally reshape biomedical research, and those who act first will lead the industry's next chapter," said Avi Minkowitz, CEO of Kala.

STRATEGIC SIGNIFICANCE: FROM INNOVATION TO COMMERCIAL EXECUTION

The launch of BIRA marks a significant turning point for Kala Bio. The Company has transitioned from platform readiness and strategic announcements to live commercial deployment precisely within the timeframe it communicated to the market. With BIRA now commercially live, the Researgency.ai platform has moved from a strategic ambition to an active revenue-generating opportunity.

Key strategic milestones achieved include transitioning from platform readiness to live commercial deployment, deploying operational enterprise-grade AI infrastructure, implementing a scalable platform architecture, creating an active, revenue-generating opportunity, and establishing a full platform commercialization roadmap.

The Bionic Intelligence Research Agent integrates seamlessly with Younet's Researgency platform infrastructure and is designed to complement, not replace, existing multi-LLM research workflows. Its design scales with organisational complexity, leverages existing enterprise infrastructure investments, and supports a platform-as-a-service model aimed at generating recurring revenue.

MARKET OPPORTUNITY & COMPETITIVE POSITIONING

With thousands of biotech and pharma companies worldwide facing research bottlenecks, compliance challenges, and competitive intelligence issues, BIRA is positioned to tap into a significant market opportunity. The target market includes the global biotechnology and pharmaceutical sectors. The platform's main differentiation is its on-premises secure deployment model compared to public cloud AI options. Its core value proposition focuses on proprietary data control combined with enterprise-scale AI performance, while the revenue model is based on platform-as-a-service with scalable recurring income potential.

Kala is now an operational AI infrastructure partner to the global biotech industry, delivering industry-leading solutions that combine next-generation agentic capabilities with uncompromising security, though no assurance can be given that it will capture any specific portion of that market, or that its efforts in that market will generate substantial recurring revenue or be profitable.

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 Delivers Industry-Leading AI Infrastructure: Bionic Intelligence Research Agent Now Live