Trooperstocks
2月前
$KALA News: Kala Bio Celebrates Trump Executive Order as Game-Changer for Psychedelic Medicine | NASDAQ
Historic U.S. Executive Order Fast-Tracks Psychedelic Research Access; Landmark Policy Shift Strengthens the Outlook for KALA’s Client Red Light Holland and Positions Researgency.ai as the Dedicated AI Infrastructure Partner for the Global Psychedelic and Biotech Drug Development Industry
ARLINGTON, Mass., April 21, 2026 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ: KALA) (“KALA” or the “Company”) today celebrated the landmark Executive Order signed by U.S. President Donald J. Trump on April 18, 2026. The Order directs the FDA to prioritize the review of psychedelic compounds, instructs the DEA to reduce research restrictions, establishes expanded patient access pathways under the Right to Try Act, and allocates $50 million in federal funding to accelerate psychedelic therapy research, representing the most sweeping shift in U.S. federal psychedelic policy in decades.
The Executive Order arrives at a pivotal moment, and KALA is uniquely and strategically positioned to capitalize on this seismic policy shift. KALA congratulates its client, Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTCQB: TRUFF) (“Red Light”), on this transformative federal policy shift. With expanded patient access pathways, reduced DEA research restrictions, and national priority review signals from the FDA, Red Light’s psychedelic drug development programs are now positioned to advance with materially stronger regulatory and commercial momentum and to deliver on the full clinical and therapeutic promise of its portfolio within a supportive federal framework. KALA is proud that Red Light’s development strategy is supported by KALA’s proprietary Researgency.ai agentic artificial intelligence platform, licensed worldwide from Younet AI.
As disclosed on March 18, 2026, Red Light engaged KALA’s Researgency.ai agentic AI platform, licensed worldwide from Younet AI, to support its clinical development strategy, including clinical planning, protocol optimization, and scenario modelling. Today’s policy announcement reinforces Researgency.ai's commercial relevance to the psychedelic drug development sector and underscores KALA’s position as the dedicated AI infrastructure partner for the broader biotechnology industry.
“President Trump’s Executive Order is the clearest signal yet that psychedelic medicine is moving from under-researched science to mainstream healthcare, and KALA is already embedded to capitalize on this revolution. We are thrilled to have Red Light Holland as one of our Researgency.ai clients, and today’s policy shift materially strengthens the outlook for their programs. As psychedelic medicine moves toward multi-session, dose-optimized protocols under a supportive federal framework, clinical development becomes materially more complex, with more variables, more patient subgroups, and more decision points. Researgency.ai delivers compounding value by providing secure, on-premises agentic AI applied to proprietary biological and clinical data. We congratulate Red Light on this transformative moment for the industry and look forward to expanding our role as the dedicated AI infrastructure partner for the psychedelic and broader biotech industries,” said Avi Minkowitz, Chief Executive Officer of KALA BIO.
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
https://www.nasdaq.com/press-release/kala-bio-celebrates-trump-executive-order-game-changer-psychedelic-medicine-2026-04
Trooperstocks
3月前
$KALA News: BIO Delivers Industry-Leading AI Infrastructure: Bionic Intelligence Research Agent Now Live
KALA BIO, Inc.
Mon, March 30, 2026 at 8:45 AM EDT
Next-Generation Agentic AI Platform Achieves Live Enterprise Deployment, Delivering Secure, Scalable, Autonomous Research Solutions to Global Biotechnology and Pharmaceutical Organizations
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
Trooperstocks
3月前
$KALA PRESS: Red Light Holland Engages Kala Bio's Researgency.ai Platform to Support Clinical Development of Filament Health's Patented PEX010 Botanical Psilocybin Drug Candidate
TMX Newsfile
Wed, March 18, 2026 at 8:15 AM EDT 8 min read
In this article: $KALA $TRUFF $TRIP $TRIP.CN
AI-powered autonomous research agents to be deployed in support of PEX010 clinical development strategy, leveraging Kala Bio's purpose-built agentic AI platform for the biotechnology industry
Toronto, Ontario and Arlington, Massachusetts--(Newsfile Corp. - March 18, 2026) - Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTCQB: TRUFF) ("Red Light" or the "Company") and Kala Bio, Inc. (NASDAQ: KALA) ("Kala Bio") today announced that Red Light has engaged Kala Bio's Researgency.ai agentic artificial intelligence platform to support the clinical development strategy for PEX010, the patented botanical psilocybin drug candidate originated by Filament Health Corp. ("Filament"). The engagement will deploy Kala Bio's purpose-built AI research agents to assist in clinical planning, protocol optimization and scenario modeling as Red Light advances PEX010 through its regulated drug development program.
Red Light recently announced a definitive arrangement agreement to acquire Filament's business, including its portfolio of 76 issued patents across 15 patent families, representing one of the largest intellectual property portfolios in botanical psilocybin drug development, as well as its lead drug candidate, PEX010.
Strategic Rationale
The engagement of the Researgency.ai platform represents a key element of Red Light’s strategy to integrate advanced AI-driven research capabilities as it looks to expand Filament’s regulated psychedelic drug development platform. By deploying Kala Bio’s purpose-built AI agents, Red Light also intends to accelerate and enhance research planning, scenario simulation, and protocol optimization processes associated with advancing PEX010 through Filament’s clinical development pipeline.
PEX010 is Filament's patented botanical psilocybin drug candidate and is currently supplied to more than 70 clinical research sites worldwide, making it one of the most widely studied botanical psilocybin drug candidates in regulated clinical research. PEX010 is being studied across multiple indications, including alcohol use disorder, methamphetamine use disorder, treatment-resistant depression, cancer-related anxiety and depression, and cannabis use disorder, at leading research institutions including Johns Hopkins University and Dana-Farber Cancer Institute, among others.
The drug candidate has received both Health Canada and U.S. Food and Drug Administration authorization for clinical trials and has demonstrated positive Phase 2 clinical data in alcohol use disorder.
Researgency.ai is an agentic AI platform developed by Younet.ai with an exclusive worldwide distribution/development license owned by Kala Bio, designed to deploy secure, on-premises AI agents purpose-built for biotechnology and pharmaceutical R&D workflows. The platform enables autonomous research loops capable of generating, simulating, and optimizing study scenarios at scale, compressing timelines and expanding the number of viable options considered before execution. The approach mirrors a broader industry shift toward purpose-built AI infrastructure for drug development.
Management Commentary
"As we move to integrate Filament's exceptional clinical assets and intellectual property, engaging Kala Bio's Researgency.ai platform is a natural next step in building a best-in-class psychedelic drug development operation," said Todd Shapiro, Chief Executive Officer and Director of Red Light Holland. "PEX010 is already one of the most widely studied botanical psilocybin drug candidates in the world. By applying autonomous AI-driven research capabilities to our clinical development planning, we believe we can accelerate timelines, strengthen study designs, and make smarter, faster decisions across PEX010's extensive clinical program."
"Filament's focus from the beginning has been to build a strong scientific and intellectual property foundation for botanical psilocybin drug development," said Ben Lightburn, Chief Executive Officer of Filament Health Corp. "With PEX010 already supporting a growing body of global clinical research, the application of advanced analytical tools such as Kala Bio's Researgency.ai platform has the potential to further strengthen how clinical development strategies are evaluated as the program continues to evolve."
"Red Light's decision to deploy Researgency.ai in support of PEX010 underscores exactly the kind of high-value, data-intensive challenge our platform was built to address," said Avi Minkowitz, Chief Executive Officer of Kala Bio. "Psychedelic drug development is a complex, rapidly evolving field where the ability to quickly simulate and evaluate clinical scenarios can make a meaningful difference. We are excited to work with the Red Light team as they advance one of the leading botanical psilocybin programs in the world."
The Company further announces that it has engaged Solidaire Investments Inc. ("Solidaire"), a Calgary, Alberta-based merchant bank, to provide capital markets advisory and investor relations consulting services. The agreement is effective immediately for a one-month term, during which the Company will pay Solidaire a fee of $20,000. Solidaire is principally owned and operated by Mohamed Elsaghir, a shareholder of the Company.
About PEX010
PEX010 is a patented botanical psilocybin drug candidate developed by Filament Health Corp. PEX010 is formulated as a capsule for oral administration and is protected by Filament's portfolio of 76 issued patents across 15 patent families covering natural psilocybin extraction, purification, standardization, stabilization, and alternative delivery formulations. PEX010 is currently supplied to more than 70 clinical research sites worldwide and is being studied in multiple Health Canada and FDA-authorized clinical trials across a range of mental health indications.
About Red Light Holland
Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTCQB: TRUFF) is a Toronto-based company advancing a focused strategy within the legal psychedelic sector, centered on voluntary data collection and R&D initiatives designed to expand naturally occurring drug development and understanding of psilocybin use and consumer experiences. The Company operates commercial activities across Europe and North America, including psilocybin truffle sales in the Netherlands' legal market and mushroom home grow kits offered through B2B and DTC channels, in compliance with applicable laws. Red Light has entered into a definitive arrangement agreement to acquire Filament Health Corp., which is expected to expand the Company's drug development platform with GMP manufacturing capabilities, comprehensive Health Canada licensing, FDA-authorized clinical programs, and a portfolio of 76 issued patents. For more information, visit www.RedLight.co.
About Filament Health:
Filament Health is a clinical-stage natural psychedelic drug development company. Filament believes that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and its mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. Filament is paving the way with the first-ever natural psychedelic drug candidates.
About Researgency.ai
Researgency.ai is an agentic AI platform developed by Kala Bio, Inc. (NASDAQ: KALA) in collaboration with Younet.ai, designed to bring autonomous research-agent workflows to biotechnology R&D planning. The platform deploys purpose-built AI agents that can simulate scenarios, optimize protocols, and support evidence-driven decisions in a secure, on-premises environment built for pharmaceutical-grade compliance. For more information, visit www.Researgency.ai.
About Kala Bio, Inc.
Kala Bio, Inc. (NASDAQ: KALA) 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 systems 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. For more information, visit www.kalarx.com.
For additional information on Red Light Holland:
Todd Shapiro
Chief Executive Officer & Director
Tel: 647-204-7129
Email: todd@redlight.co
Website: www.RedLight.co
US Market News
3月前
Younet.ai Highlights Researgency.ai Collaboration with Kala Bio (KALA) as New "AutoResearch" Milestone Signals the Rise of Autonomous Research AgentsMarch 11, 2026 11:18 AM
NewsfileOpen-source breakthrough demonstrates AI agents can run 100+ experiments overnight-reinforcing the agentic R&D paradigm Researgency.ai is bringing to life sciences with Kala Bio (KALA)Toronto, Ontario--(Newsfile Corp. - March 11, 2026) - Younet.ai, a Toronto-based AI technology company specializing in enterprise-grade private LLM solutions, today announced that the recent release of AutoResearch by AI pioneer Andrej Karpathy provides strong external validation for the autonomous research-agent approach underpinning Researgency.ai, Younet's agentic research platform being developed in collaboration with Kala Bio, Inc. (NASDAQ: KALA).AutoResearch is an open-source tool that enables AI agents to autonomously conduct 100+ machine-learning experiments overnight on a single GPU, demonstrating a step-change in research velocity via continuous agentic iteration. Younet.ai believes the same "overnight research loop" can reshape life-sciences planning and decision-making through Researgency.ai, which is being developed with Kala Bio to apply autonomous research principles to biotech R&D workflows, including scenario simulation and protocol optimization."What AutoResearch demonstrates for machine-learning experimentation is the same transformation Researgency.ai is engineered to deliver for biotech research planning—continuous agentic iteration while teams sleep," said Alex Kapralov, CEO of Younet.ai. "With Researgency.ai and our collaboration with Kala Bio (NASDAQ: KALA), the goal is to help life-sciences teams wake up to better study designs, stronger protocol options, and faster evidence-driven decisions."AutoResearch: A Public Blueprint for Autonomous DiscoveryAutoResearch has been described as a compact framework that changes how experimentation can be conducted by enabling an agent to:Modify code, run experiments, and evaluate results autonomouslyContinuously iterate (~12 experiments per hour; 100+ overnight)Self-evaluate and keep improvements while discarding failuresOperate efficiently on a single GPU, lowering the barrier to high-frequency experimentationKarpathy has described the aspiration as enabling faster research progress "indefinitely" and without ongoing human involvement—an approach Younet.ai views as aligned with the agentic future emerging across R&D and knowledge work.Researgency.ai with Kala Bio (NASDAQ: KALA): Autonomous Research Principles Applied to Life SciencesReseargency.ai is an agentic AI platform under development with Kala Bio (NASDAQ: KALA) intended to bring autonomous research loops to biotechnology R&D planning. The platform aims to translate "100 experiments overnight" into "100 study scenarios overnight" by enabling agents to autonomously plan, simulate, and optimize research scenarios around the Researgency lock.The Agentic Research Loop (Life Sciences Analogy)1) Define Objectives (Human Input)Teams define objectives, constraints, and evaluation criteria (e.g., endpoints, budgets, timelines, and enrollment feasibility).2) Autonomous Agent Loop (AI Execution)Agents generate protocol parameters, simulate scenarios across site and enrollment configurations, model statistical power under varying assumptions, and evaluate pathway alignment—iterating continuously and retaining the most promising configurations.3) Morning Review (Human Strategy)Teams review prioritized outputs, compare optimized configurations, and make decisions based on structured scenario results rather than purely sequential, manual iteration.Real-World Signal: Autonomous Agents Already Deliver Measurable GainsThe AutoResearch narrative includes a public example in which Shopify's CEO reported using AutoResearch overnight and seeing a 19% improvement in validation scores, with an agent-optimized smaller model outperforming a larger manually tuned counterpart—underscoring the potential impact of autonomous iteration.Younet.ai views this as an early indicator that agentic approaches can deliver compounding improvements when applied to complex optimization problems—an effect Researgency.ai seeks to translate into life-sciences planning and execution contexts in collaboration with Kala Bio (NASDAQ: KALA).Strategic Context: From Manual R&D Cycles to 24/7 Autonomous IterationReseargency.ai is intended to help shift life-sciences organizations away from manual, sequential planning cycles toward higher-frequency parallel scenario exploration—compressing timelines and expanding the number of viable options considered before execution."The core shift is moving from human-limited iteration speed to always-on autonomous exploration," Kapralov added. "Researgency.ai is being built to help teams evaluate more options, faster—so the best strategies rise to the top sooner."About AutoResearchAutoResearch is an open-source Python tool created by Andrej Karpathy that enables AI agents to autonomously conduct machine-learning experiments and iterate on results with minimal human involvement. AutoResearch has been cited by industry leaders as evidence of a broader shift toward autonomous AI-driven research workflows.About Researgency.aiReseargency.ai is an agentic AI platform under development with Kala Bio (NASDAQ: KALA) to bring autonomous research-agent workflows to biotechnology R&D planning—enabling AI agents to simulate scenarios, optimize protocols, and support evidence-driven decisions around the clock. The platform leverages Younet.ai capabilities in private LLM infrastructure and retrieval-augmented generation (RAG).About Younet.aiYounet.ai is a Toronto-based AI technology company specializing in enterprise-grade private LLM solutions. The company's platform hosts thousands of custom AI agents and features advanced retrieval-augmented generation (RAG) capabilities. For more information, visit www.younet.ai.About Kala Bio, Inc.Kala Bio, Inc. (NASDAQ: KALA) is a biopharmaceutical company exploring innovative approaches to drug development and life-sciences research. For more information, visit www.kalarx.com.Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding the development, capabilities, expected benefits, and potential applications of Researgency.ai; the anticipated impact of autonomous research agents on life-sciences research and development; and Younet.ai's collaboration with Kala Bio, Inc. (NASDAQ: KALA). Forward-looking statements are based on management's current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the ability to develop and deploy new technologies, the performance and reliability of AI models and simulations, data availability and quality, cybersecurity and privacy considerations, regulatory considerations, market adoption, and other risks. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Younet.ai undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this release, except as required by law. Kala Bio's filings with the U.S. Securities and Exchange Commission may also identify and discuss additional risks and uncertainties.Media Contact (Younet.ai)
Matt Rasner
m.rasner@younet.aiTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/288115
Original: Younet.ai Highlights Researgency.ai Collaboration with Kala Bio (KALA) as New "AutoResearch" Milestone Signals the Rise of Autonomous Research Agents
Trooperstocks
3月前
$KALA News: Kala Bio Launches a Revolution for Biotech- First AI Agent Deploying in 14 Days as $180 Billion Agentic AI Healthcare Revolution Accelerates
KALA BIO, Inc.
Wed, March 11, 2026 at 6:30 AM EDT 8 min read
Platform Rebrand of Researgency.ai; First Purpose-Built AI Agent for Biotech Expected to Ship Within Two Weeks
ARLINGTON, Mass., March 11, 2026 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ: KALA) announces that it is ready to ship its first commercial AI product in approximately 14 days, transforming the Company from a clinical-stage biotech into a dual-engine growth story powered by both a proprietary drug pipeline and a scalable AI platform targeting the $180+ billion AI-in-healthcare market. Kala is building the Palantir for biotech, just as Palantir built a $250+ billion company by helping governments and enterprises make sense of massive data, Kala is doing the same for the biotech and pharmaceutical industry through its Researgency.ai platform, deploying purpose-built AI agents that handle the repetitive, high-stakes jobs that slow drug companies down, faster, cheaper, and with fewer errors than humans.
THE PLATFORM IS LIVE. THE FIRST PRODUCT IS SHIPPING.
With the full rebrand of Researgency.ai now complete, the platform is live and ready for enterprise clients. Kala’s scientists, working alongside Younet’s AI engineering team, are building the Company’s first custom AI agent right now, with delivery expected in approximately 14 days. This is not a rebranding announcement — this is a go-to-market readiness signal.
“The rebrand was important, but the real story is what happens next, we launch,” said Avi Minkowitz, CEO of Kala. “We are building the Palantir for biotech. Our first agent ships in 14 days, and our team is fired up. This is the beginning of something big.”
WHY NOW: THE AGENTIC AI MEGATREND IS HERE
The world’s largest companies are racing to adopt agentic AI, software that doesn’t just answer questions, but actually does the work. Block, Inc. recently committed to an agentic operating model; Gartner reports a 1,445% surge in enterprise inquiries about multi-agent AI systems from Q1 2024 to Q2 2025; and the global AI-in-healthcare market is projected to exceed $180 billion by 2030. While most AI companies chase general-purpose markets, Kala is laser-focused on biotech and pharma, the most data-intensive, compliance-heavy, and highest-value industry in the world.
WHY BIOTECH IS THE PERFECT MARKET FOR AI AGENTS
Biotech and pharma companies are drowning in complex, expensive, time-sensitive work. Every day spent on paperwork and compliance is a day a life-saving drug isn’t getting to patients. Kala’s AI agents target three massive pain points: repetitive workflows that AI can run on autopilot; mountains of paperwork where one mistake can delay a drug by months; and costly delays where AI compresses work from weeks to days, or even hours.
WHAT KALA'S AI PLATFORM CAN DO
Researgency.ai is a full enterprise platform where companies can design, deploy, and improve AI agents in a secure, auditable environment built for pharma-grade compliance, the operating system for AI in biotech. High-value use cases include:
Research Intelligence Agent — Monitors scientific publications and competitor activity, delivering structured summaries.
Clinical Trial Agent — Drafts study protocols, runs consistency checks, and prepares trial documentation.
Regulatory & Compliance Agent — Drafts controlled documents, tracks revisions, and ensures FDA submissions are complete and formatted correctly.
Safety & Pharmacovigilance Agent — Monitors drug safety signals, organizes case reports, and flags issues for escalation.
Commercial Launch Agent — Generates training materials, product fact sheets, and launch playbooks so teams are ready the moment a drug is approved.
WHAT THIS MEANS FOR KALA INVESTORS
The old Kala was a one-drug story, high risk, binary outcomes. The new Kala is a dual-engine growth company: a Biotech Pipeline advancing cutting-edge treatments with FDA Orphan Drug and Fast Track designations, plus Researgency.ai, an AI platform any biotech or pharma company can use, generating recurring revenue month after month. There are thousands of biotech and pharma companies worldwide facing the exact pain points Kala is solving. Kala is positioning itself as the go-to AI infrastructure partner for the biotech industry, no longer a single-asset bet, but a platform company with the potential to serve an entire industry.
Early investors in platform companies that successfully execute have historically seen some of the biggest returns in the market.
NEXT CATALYST: FIRST AI AGENT SHIPS IN ~14 DAYS
Kala confirmed that its first AI Researgency agent is actively being built and is expected to ship within approximately 14 days. After launch, the Company will share full details, which workflow it targets, what the agent does, and exactly how it will measure value delivered. For investors, this is the moment the platform story moves from strategy to execution.
About KALA BIO (NASDAQ: KALA)
KALA BIO, Inc. (NASDAQ: KALA) 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 systems 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 companies of all sizes to unlock the value of their proprietary biological data without ever surrendering control of it. 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. Kala believes the future of biomedical innovation will be shaped by organizations that can safely and effectively operationalize agentic systems as a core capability, or in short, the future of bio-med is Agentic bio-med.
For more information, visit www.kalarx.com; 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.
For more information:
www.kalarx.com
www.Researgency.ai
Contact:
Avi Minkowitz
Chief Executive Officer
am@kalarx.com
ProfitScout
3月前
KALA BIO Announces Strategic Initiative to Deploy and Continue to Develop an On-Premises AI Infrastructure Platform for the Biotech Industry; Enters Into Platform Development and Exclusive License Agreement for Proprietary AI Research Platform “Researgency”
Company launches initiative to become a dedicated AI infrastructure partner for the biotechnology industry — to deploy secure, on-premises AI systems directly within client environments where proprietary data never leaves the client’s control
Platform-as-a-service model designed to generate recurring revenue by licensing AI capabilities to biotech and pharmaceutical companies of all sizes — addressing a market where the top 20 pharma companies invested approximately $167 billion in R&D in 2024 but have only recently begun to deploy meaningful AI budgets
KALA to serve as its own first deployment client, applying Researgency to its proprietary MSC-S biological datasets and KPI-012 clinical program before scaling to external biotech partners
Exclusive worldwide license secured for the Researgency platform in the biotechnology field for an initial 12-month term with successive renewal options; platform architecture designed from inception for multi-client deployment
On-premises, data-sovereign architecture will differentiate Researgency from centralized AI platforms — will enable biotechs to leverage institutional-grade AI without surrendering control of their most valuable intellectual property
ARLINGTON, Mass., March 04, 2026 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ: KALA) (“KALA” or the “Company”), a clinical-stage biopharmaceutical company, today announced a strategic initiative to build a biotechnology industry dedicated, on-premises artificial intelligence (“AI”) infrastructure platform, designed to be deployed directly within biotech and pharmaceutical client environments, enabling companies across the life sciences sector to unlock additional potential of their proprietary biological data without ever surrendering control of it.
The Company also announced that it has entered into a Platform Development and Exclusive License Agreement (the “Agreement”) with 2624465 Ontario Inc., operating as Younet AI (“Younet”), for a proprietary AI research platform, internally designated “Researgency,” designed to deploy custom, secure, large language models (“LLMs”) purpose-built for biomedical research and data science applications. The Agreement provides KALA with initial platform access during a 12-month initial term and the option, in KALA’s sole discretion, to extend the Agreement for successive 12-month renewal terms.
The Vision: AI Infrastructure for the Entire Biotech Industry
The biotechnology industry faces a fundamental structural problem: thousands of small and mid-cap biotech companies are generating enormous volumes of proprietary biological data, from preclinical studies, clinical trials, genomic sequencing, protein interaction mapping, and secretome analysis, but the vast majority of these companies lack the internal resources, infrastructure, or specialized talent to deploy advanced AI capabilities against that data. At the same time, these companies are rightly unwilling to surrender their most sensitive intellectual property, the biological data, trade secrets, and clinical datasets that represent years of investment and form the core of their competitive advantage, to centralized, third-party cloud platforms.
KALA intends to solve this problem. The Company’s vision is to serve as a dedicated AI infrastructure partner for the biotechnology industry, deploying the Researgency platform directly within each client’s own secure environment, on their own servers, under their own control. In this model, KALA would provide the AI platform, the purpose-built biomedical agents, and the ongoing optimization, while the client would retain full ownership and custody of their data at all times. No proprietary information would ever leave the client’s infrastructure. No biological data would be shared with public AI services.
The Company believes this on-premises, data-sovereign approach represents a fundamentally different model from the centralized AI platforms currently operating in the life sciences space. While established AI drug discovery companies, including well-funded, publicly traded platforms with billion-dollar market capitalizations, typically require clients to upload proprietary data to centralized cloud environments, KALA’s architecture is designed from inception to go to the client, not the other way around. The Company believes this distinction is critical in an industry where intellectual property, trade secrets, and regulatory-sensitive data represent the most valuable assets a company possesses. Younet’s current go to market strategy is focused on morphing and tech augmenting existing operating companies into Agentic Companies where a large bulk of repeat and time consuming tasks and research are passed on to teams of proprietary agents. KALA intends to build on top of this approach and implement Agentic Company strategy in biomedical field.
“We are not building another centralized AI platform that asks biotechs to hand over their crown jewels,” said Avi Minkowitz, Chief Executive Officer of KALA BIO. “We are building the opposite. We want to be the company that shows up at the biotech company’s door, deploys institutional-grade AI on the biotech company’s servers, makes the biotech company’s data smarter, and never takes it from the biotech company. Hundreds of biotech companies are sitting on proprietary biological data that could yield breakthrough insights, but they cannot build this infrastructure themselves, and they should not have to trust a third party with their most sensitive assets. That is the gap we are filling. We intend to be an AI backbone of the biotech industry.”
The Market Opportunity: A $167+ Billion R&D Ecosystem Underserved by AI
The global AI drug discovery market is projected to grow at a compound annual growth rate approximately 25%,1 driven by AI’s demonstrated ability to compress traditional drug development timelines, which historically average 10 to 15 years and cost up to $2.6 billion per approved drug,2 to potentially as little as 12 to 18 months for preclinical candidate nomination, while reducing costs by an estimated 30 to 40 percent.3 Dozens of AI-designed drug candidates are currently in clinical trials globally, up from only three in 2016,4 with the first AI-discovered drug approvals anticipated in the near term.
The world's twenty largest pharmaceutical companies collectively invested approximately $167 billion in research and development in 2024,5 yet the pharmaceutical industry's combined investment in AI-driven drug discovery was estimated at approximately $4 billion in 2025, expected to grow to approximately $25 billion by 2030.6 The Company believes this represents one of the largest technology adoption gaps in any major industry.
More importantly, the Company believes the addressable market for on-premises, secure, purpose-built AI infrastructure, specifically designed for small and mid-cap biotech companies that cannot afford to build in-house AI capabilities and are unwilling to send proprietary data to centralized platforms, is substantially underserved. There are over 3,200 biotechnology companies in the United States alone,7 the majority of which are generating biological data that could benefit from AI-driven analysis but lack a viable, secure path to deploying it. KALA believes this segment represents a significant near-term revenue opportunity for a platform specifically architected to serve their needs.
What Is Researgency and How Does It Work?
Researgency is a proprietary biomedical AI research platform licensed to KALA by Younet AI, a specialized artificial intelligence development firm with experience deploying over 100 custom AI agents for enterprise clients across healthcare, technology, and life sciences sectors.
The platform is expected to be capable of deploying fully on-premises, secure AI systems that operate independently of any public AI service. In practical terms, Researgency works as follows: instead of relying on large teams of researchers to manually review thousands of scientific papers, clinical datasets, and biological records, a biotech company deploys purpose-built AI “agents”, specialized digital assistants trained exclusively on biomedical and pharmaceutical data, that can perform these tasks faster, more comprehensively, and at a fraction of the cost. Each agent is designed for a specific research function, such as analyzing protein interactions, reviewing drug safety literature, identifying new therapeutic targets, or modeling clinical trial outcomes. Intended narrow specialty of the agents shall significantly reduce hallucinations and save time on error corrections.
The platform’s core architecture includes advanced retrieval-augmented generation (“RAG”) pipelines, scalable AI infrastructure, and proprietary training algorithms that have been validated through a completed feasibility study confirming adaptability to the complex analytical demands of biomedical research, drug discovery, and clinical data science.
Key technical differentiators include:
On-Premises Deployment: The entire AI system operates within the client’s own secure infrastructure. No data is transmitted to external servers, public clouds, or third-party AI services.
Custom Agent Architecture: Purpose-built AI agents are configured specifically for each client’s therapeutic focus areas, data types, and research objectives, not generic, one-size-fits-all models.
Full Data Sovereignty: Proprietary biological data, trade secrets, and intellectual property remain entirely under the client’s control at all times, meeting the highest standards of regulatory compliance and IP protection.
Scalable Infrastructure: Platform architecture is designed from inception for multi-client deployment, enabling KALA to onboard additional biotech clients without rebuilding core systems.
The Platform Revenue Model: From Internal Tool to Industry Infrastructure
KALA intends to deploy the Researgency platform in a phased approach designed to validate performance, demonstrate value, and scale across the biotechnology industry:
Phase 1 — Internal Validation (Current): KALA serves as its own first deployment client, applying Researgency’s AI capabilities to the Company’s proprietary MSC-S platform datasets, KPI-012 preclinical and clinical data, and existing intellectual property portfolio. The Company expects to complete its initial AI-driven reassessment of historical datasets and report preliminary findings during the 12-month initial term.
Phase 2 — External Deployment: Following successful internal validation, KALA intends to begin licensing the Researgency platform to external biotech and pharmaceutical clients on a recurring subscription basis. Each deployment would be customized for the client’s specific therapeutic focus, data environment, and research objectives, with the platform installed directly on the client’s own infrastructure.
Phase 3 — Platform Expansion: As the client base grows, KALA intends to expand Researgency’s capabilities to include advanced predictive modeling for drug discovery workflows, AI-powered hypothesis generation and experimental design, secure regulatory-compliant data management, and collaborative research tools for academic institutions, CROs, and pharmaceutical partners.
This phased approach is designed to transform KALA from a single-pipeline clinical-stage biopharmaceutical company into a platform company with recurring, scalable revenue derived from licensing AI infrastructure to the broader biotechnology industry, while simultaneously enhancing the value of KALA’s own therapeutic programs.
Competitive Positioning: Why On-Premises Matters
The Company believes the current AI drug discovery landscape is dominated by centralized platform models that require biotech companies to upload proprietary data to third-party cloud environments. While these platforms have demonstrated the power of AI in drug discovery, they present significant barriers for the thousands of biotech companies whose proprietary biological data, trade secrets, and regulatory-sensitive information represent their most valuable assets.
KALA’s on-premises, data-sovereign model is designed to address this gap directly. The Company believes the competitive moat of the Researgency platform is built on several key advantages:
Exclusive License: KALA holds exclusive worldwide rights to the Researgency platform within the biotechnology field.
Data Never Leaves the Client: Unlike centralized models, the Researgency platform deploys within the client’s own environment. This eliminates a large barrier to AI adoption among data-sensitive biotech companies.
Deep Customization: Each deployment features purpose-built AI agents tailored to the client’s specific datasets and therapeutic areas, creating high switching costs and long-term client retention.
Platform Network Effects: As KALA deploys across multiple clients, the Company’s understanding of biomedical AI agent design, RAG pipeline optimization, and deployment best practices should increase — creating an operational expertise moat that is expected to grow with each new deployment.
How KALA Intends to Use Researgency Internally
As its own first deployment client, KALA intends to apply AI-driven analytical tools through the Researgency platform to:
Reassess historical preclinical and clinical datasets — including the substantial biological data generated by the Company’s MSC-S platform across growth factors, protease inhibitors, matrix proteins, and neurotrophic factors
Identify additional therapeutic indications or development pathways — by using AI to detect patterns in complex, multi-factorial biological data that conventional research methods may have overlooked
Optimize trial design and probability-of-success modeling — reducing the time and cost associated with future clinical programs
Support regulatory and commercialization strategy evaluation — including analysis of the Company’s existing FDA Orphan Drug and Fast Track designations for its KPI-012 product candidate
Automate literature review and competitive intelligence — enabling the Company to continuously monitor developments across the rapidly evolving AI-biology landscape
The Company expects to report preliminary findings from its internal AI-driven data reassessment during the 12-month initial term, providing investors with tangible evidence of the platform’s capabilities prior to external deployment.
License Agreement and Terms
Under the Agreement, KALA has secured exclusive worldwide license rights to the Researgency platform within the biotechnology field (as defined in the Agreement) and has received initial platform access to evaluate and demonstrate its capabilities. The exclusivity applies to the custom, dedicated platform configured for KALA and does not restrict Younet from operating its standard, generally available, multi-tenant SaaS platform. The Company intends to assess the platform’s performance during the 12-month initial term and, subject to satisfactory results, may elect to extend the Agreement for successive 12-month renewal terms, which would include expanded deployment of custom biotechnology-focused AI agents, RAG pipeline optimization, and full-scale integration with the Company’s proprietary data systems.
The Agreement will be filed as an exhibit to the Company’s Current Report on Form 8-K with the Securities and Exchange Commission. Investors are encouraged to review the full text of the Agreement for complete terms and conditions.
Management Commentary
“The opportunity we see is simple but enormous,” said Avi Minkowitz, Chief Executive Officer of KALA BIO. “The biotech industry is generating more biological data than ever before, and the companies that can analyze that data fastest, find the patterns others miss, and translate those insights into therapies will help define the next era of medicine. But here is the problem: building AI infrastructure is expensive, complex, and requires specialized talent that most biotechs don’t have. And the existing options ask biotech companies to hand their most sensitive data to someone else’s cloud. We are building a third path, we expect to bring the AI to biotech companies, it will run on biotech companies’ servers, the data will stay with the biotech companies, and they will get the analytical information that the largest pharmaceutical companies obtain internally. That is the future we are investing in.”
Mr. Minkowitz continued: “We are starting with ourselves. KALA is client number one. We will prove this platform on our own data, our MSC-S platform, our KPI-012 program, our IP portfolio. And once we have demonstrated what it can do, we intend to make it available to the broader biotech industry. We believe the companies that win in the next decade will not be the ones with the most data, they will be the ones with the best AI infrastructure to extract value from that data. KALA intends to be a company that provides that infrastructure.”
Capital and Corporate Matters
The Company maintains an effective registration statement with the U.S. Securities and Exchange Commission, providing flexibility to access public capital, subject to market conditions and regulatory compliance. The Company may also attempt to raise capital privately. However, there is no assurance that the Company will be able to raise capital on favorable or acceptable terms.
About KALA BIO, Inc.
KALA BIO, Inc. (NASDAQ: KALA) 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 systems directly within biotech and pharmaceutical client environments. Through its exclusive license for the Researgency AI research platform, KALA intends to serve as the dedicated AI infrastructure partner for the biotechnology industry, enabling companies of all sizes to unlock the value of their proprietary biological data without ever surrendering control of it. For more information, 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, 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
AM@kalarx.com
__________________________
The Company has not independently verified the data or projections from third-party sources cited below. Such data involves risks and uncertainties and is subject to change based on various factors.
1 Mordor Intelligence, Artificial Intelligence in Drug Discovery Market — Size, Share & Trends Analysis Report (February 2026), estimating a CAGR of 25.94% from 2026–2031. See also Grand View Research, Artificial Intelligence in Drug Discovery Market Report, 2026–2033 (October 2024), estimating a CAGR of 24.8%.
2 Deloitte, Measuring the Return from Pharmaceutical Innovation (March 2025), reporting an average cost of $2.23 billion per drug for the world's 20 largest pharmaceutical companies in 2024. See also Mulcahy, A. et al., "Use of Clinical Trial Characteristics to Estimate Costs of New Drug Development," JAMA Network Open, Vol. 8, No. 1, e2453275 (January 2025), estimating a mean R&D cost of $1.31 billion per new drug approved by the FDA in 2019, after adjusting for cost of capital and discontinued products. Drug development timelines of 10 to 15 years are widely reported in peer-reviewed literature and industry analyses. See, e.g., U.S. Department of Health and Human Services, ASPE, Drug Development (October 2024); Human Specific Research, The Reality of Drug Discovery and Development (November 2025).
3 McKinsey & Company, Generative AI in the Pharmaceutical Industry: Moving from Hype to Reality (January 2024), estimating up to 50% cost reductions in clinical trial processes, and FounderNest, citing McKinsey & Company and industry data, reporting AI platforms can cut drug discovery costs by up to 40% and compress timelines from 5–6 years to 12–18 months for preclinical candidate nomination.
4 Jayatunga, M.K.P. et al., "AI in small-molecule drug discovery: A coming wave?" Nature Reviews Drug Discovery (2022), as cited in the CAS Insights report, "AI Drug Discovery: Assessing the First AI-Designed Drug Candidates to Go into Human Clinical Trials" (June 2024). See also PMC, "AI In Action: Redefining Drug Discovery and Development" (February 2025), documenting growth from 3 AI-designed clinical candidates in 2016 to 67 by 2023.
5 Hardman & Co, 2024 Pharma Statistics (April 2025). Cumulative R&D spend by the top 20 pharmaceutical companies by sales was $166.8 billion in 2024 ($153.1 billion in 2023). Total R&D spend across Hardman & Co's universe of 45 pharma companies was $194.3 billion in 2024.
6 FounderNest, Pharma at an Inflection Point: Investment Trends 2024–2025 (December 2025), reporting that 95% of pharmaceutical companies now invest in AI, with aggregate AI spending expected to grow from approximately $4 billion in 2025 to $25 billion by 2030. See also McKinsey & Company (January 2024), estimating generative AI could generate $60 billion to $110 billion in annual economic value for the pharmaceutical and medical-product industries.
7 IBISWorld, Biotechnology in the US — Number of Businesses (2025), reporting 3,229 biotechnology businesses in the United States as of 2025 (NAICS classification).
https://www.globenewswire.com/newsroom/ti?nf=OTY2NTQ0OCM3NDY2Mzg0IzIwODkyODU=
https://ml.globenewswire.com/media/ODQzNTUwN2UtMjRhZC00ZGI4LWI1ODctOTBiNmZlMDQzOWU2LTExMDA4NTYtMjAyNi0wMy0wNC1lbg==/tiny/KALA-BIO-Inc-.png
Source: KALA BIO, Inc.
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